Medicines, 2013
Shortlist up to four to read them side by side.
1,376 medicine recalls FDA’s Enforcement Report published in 2013, newest first; 18,075 in all since 2012.
FDA’s medicine recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 5, 2026.
1,376of 1,376 medicine recallsshown with your filters
The list
- Medicine recall Testosterone Pellets 225mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medicine recall Testosterone Pellets 25mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medicine recall Testosterone Pellets 37.5mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medicine recall Testosterone Pellets 50mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medicine recall Testosterone Pellets 75mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medicine recall Testosterone Propionate. 100mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medicine recall Tetracaine 2%, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medicine recall Tetracaine 2%/Pontocaine, 60ml Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medicine recall Triamcinolone Diacetate 40mg 2ml PF, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medicine recall Triamcinolone Diacetate 40mg 5ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medicine recall Triamcinolone PF 40mg 2ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medicine recall Triamcinolone 40mg PF 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medicine recall Triamcinolone Diacetate 40mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medicine recall Triamcinolone 40mg PF 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medicine recall Triamcinolone Acetonide 40mg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medicine recall Tri-Mix SS Pap 30mg, Phen 1mg, PGE1 10mcg 10ml, Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medicine recall Tri-Mix SS Pap 30mg, Phen 1mg, PGE1 10mcg 5ml, Main Street Compounding Pharmacy, 126 East Main Street,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medicine recall Trypan Blue 0.15% 1ml , Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059,… The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medicine recall Wydase 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone… Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medicine recall Wydase 5ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 Lack of Assurance of Sterility Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medicine recall Valacyclovir HCl Tablets, 500 mg, 100 tablets Subpotent Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Badger Baby Broad Spectrum SPF 30 Zinc Oxide Sunscreen Lotion Chamomile & Calendula, 4fFl.oz Tube Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen Lotion were recalled due to microbial contamination. Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and American Samoa named
- Medicine recall Badger Kids Broad Spectrum SPF30 Zinc Oxide Sunscreen Lotion Tangerine & Vanilla, 4 fl Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen Lotion were recalled due to microbial contamination. Class IIFDA’s classDec 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 11, 2013ClassClass IIStatusTerminatedWhereNationwide, and American Samoa named
- Medicine recall PACLITAXEL INJECTION, USP (semisynthetic) Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the “Clinical Studies” and “Specific Adverse Events” sections. Class IIIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 4, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1) Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cetacaine Liquid Topical Anesthetic Subpotent Drug: Cetacaine Topical Anesthetic Liquid is being recalled because one of the three active ingredients, tetracaine, is below the specification limit… Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1.2% and 2.5% Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an incorrect expiration date assigned to a lot of physicians… Class IIIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2013ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall J.R. Jack Rabbit All Natural Herbal Supplement, One tablet can last 24-72 hours, 4-count tablets per blister… Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that J.R. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Loratadine, USP 10 mg, Antihistamine Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken tablets. Class IIIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle Resuspension Problems: Recalled lot did not meet resuspendability requirements. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acetaminophen suspension liquid, 160 mg/5 mL, dye-free cherry flavor, co-packaged with an oral dosing syringe… Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acetaminophen suspension liquid, 160 mg/5 mL, cherry flavor, 2 FL OZ Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acetaminophen suspension liquid, 160 mg/5 mL, dye-free grape flavor, 2 FL OZ Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acetaminophen suspension liquid, 160 mg/5 mL, grape flavor, 2 FL OZ Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Scalp Oil), 118.28 mL Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm’s routine testing. Class IIIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 27, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm’s routine testing. Class IIIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 27, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Omeprazole Delayed-Release Capsules, USP, 20 mg Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereKentucky and Tennessee
- Medicine recall Spironolactone tablets, USP 25 mg Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a… Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Spironolactone tablets, USP 50 mg Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a… Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Metoclopramide Injection, USP 10 mg Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Ondansetron Injection, USP, 4 mg/2 mL Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a… Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Affirm XL Nutritional Supplement, 1 and 10 count blister packs and single pill packs Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain sulfoaildenafil, an analogue of sildenafil which is an ingredient in an… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 27, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES Failed dissolution specifications; 18 month CRT Class IIFDA’s classNov 13, 2013in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereIllinois, New Hampshire, New Jersey, New York, Ohio, Rhode Island and Tennessee
- Medicine recall Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Amlodipine Besylate Tablets, USP, 2.5 mg CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Drug recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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