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 Maalox, Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wintergreen flavor, 50-count… Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging. Class IIIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 600 mg/60… Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging. Class IIIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500… Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging. Class IIIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500… Labeling: Incorrect or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging. Class IIIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) Defective Container; Small micro fracture observed in the 2-Liter bottle at the fill line resulting in a small leak when patient reconstitutes the bulk powder Class IIIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 28, 2013ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and Lack of Assurance of Sterility; Lack of Assurance of Sterility; product not manufactured under sterile conditions as required for ophthalmic drug products Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months. Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tagitol V Barium Sulfate Suspension Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity. Class IIIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL Crystallization: Active pharmaceutical ingredient is precipitating in product solution. Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CLENZIderm M.D cGMP Deviations; during the production process, CLENZIderm M.D. Class IIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alprostadil IN NS Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Atropine Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bacteriostatic Water for Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BiMix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cidofovir Opthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cyclosporine Ophthalmic, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Diazepam Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dexamethasone PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DMSO Aqueous Irrigation 50%, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Gentamicin Sulfate Irrigation, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HCG Chorionic Gonadotropin, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydroxyprogesterone CAPR.(G.S.), compounded by Pallimed Solutions Pharmacy, Woburn MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylcobalamin PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MIC with B6 and B12, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nandrolone Decanoate Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Quadmix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tacrolimus Ophthalmic, Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Cypionate/Testosterone Enanthate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Cypionate/Propionate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Cypionate Injection,compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Trimix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vancomycin Ophthalmic PF, compounded by Pallimed Solutions Pharmacy, Wobrun, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Verapamil Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Prednisone Tablet USP, 20 mg tablets Labeling: Missing Label; missing label on blister card Class IIIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC… Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum Strength Acid Reducer, 65 count… Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120… Presence of foreign substance: One lot of the product may contain black foreign particles Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Rifadin (rifampin) capsules, USP, 150 mg, 100-count capsules per bottle Subpotent Drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with the… Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Propofol Injectable Emulsion, 1%, 1 g/100 mL Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clobetasol Propionate Cream, USP, 0.05%, 15 grams Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. Class IIIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 21, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall 3M Tekk Brand Industrial/Construction First Aid Kit, Total Resources Int’l Walnut, CA 91789 CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient… Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Medi-First Brand First Aid Kit, MEDI-FIRST 61 Piece Kit, Home, Workplace Travel, Sport, Total Resources… CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient… Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall (No Brand) First Aid Kit, 326 Piece Kit CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient… Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10… Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds. Class IIIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall REEVA (triclosan) Antibacterial Hand Soap and Dishwashing Liquid, Green Apple, 0.10%, 24 fl oz Microbial Contamination of a Non-Sterile Products: Product was found to be contaminated with the bacteria, Sarcina Lutea. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL Presence of Particulate Matter: Found during examination of retention samples. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Lightning ROD capsules, 500 mg/capsule Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IStatusTerminatedWhereNationwide
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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