Medicines, 2017
Shortlist up to four to read them side by side.
1,073 medicine recalls FDA’s Enforcement Report published in 2017, 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.
1,073of 1,073 medicine recallsshown with your filters
The list
- Medicine recall METRONIDazole Injection, USP 500 mg Lack of Sterility Assurance: customer report of leaking bag Class IIFDA’s classMar 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (NDC 66758-208-58) Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating “Do cut the patch” rather than the correct instructions of… Class IIFDA’s classMar 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Glipizide 2.5 mg ER Tablets Failed Dissolution Specifications Class IIFDA’s classMar 1, 2017in FDA’s Enforcement ReportFloridathe one state its words name PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereFlorida
- Medicine recall MakeSense PHARMA, HEMORRHOIDAL RELIEF CREAM Phenylephrine HCL-0.25% Zinc Oxide-12.50%,1 oz. CGMP Deviations Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report5 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereFlorida, Illinois, Michigan, New York and Pennsylvania
- Medicine recall MakeSense PHARMA FIRST AID CREAM Lidocaine HCL 0.5%, Phenol 0.5%, 1 oz.. CGMP Deviations Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report5 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereFlorida, Illinois, Michigan, New York and Pennsylvania
- Medicine recall MakeSense PHARMA Medicated ANTI-ITCH CREAM WITH SOOTHING ALOE VERA AND VITAMIN E, Camphor-1% Menthol-1%,… CGMP Deviations Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report5 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereFlorida, Illinois, Michigan, New York and Pennsylvania
- Medicine recall MakeSense PHARMA ANTIFUNGAL CREAM 1 oz CGMP Deviations Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report5 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereFlorida, Illinois, Michigan, New York and Pennsylvania
- Medicine recall MakeSense PHARMA ANTIFUNGAL CREAM Clotrimazole 1%, 1.25 oz. CGMP Deviations Class IIFDA’s classMar 1, 2017in FDA’s Enforcement Report5 statesnamed in where it went PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereFlorida, Illinois, Michigan, New York and Pennsylvania
- Medicine recall Levothyroxine Sodium 135 mcg/Liothyronine 15 mcg SR capsules, 90 count bottles Superpotent Drug and Subpotent Drug; potency failures obtained Class IIFDA’s classMar 1, 2017in FDA’s Enforcement ReportTexasthe one state its words name PublishedMar 1, 2017ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Q Care Continue Care Kit for the non-ventilated patient Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Care kit is printed with an expiration date of November 13,… Class IIIFDA’s classMar 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall MegaJex Herbal Supplement, Maximum Formula for Men, Fast acting, Increase Stamina, 20 capsules, MS Bionics,… Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active pharmaceutical ingredients in FDA approved drugs used to… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 22, 2017in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 22, 2017ClassClass IStatusTerminatedWhereCalifornia
- Medicine recall SLIMFIT X capsules Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 22, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 22, 2017ClassClass IStatusTerminatedWhereMaryland and New Jersey
- Medicine recall Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules. Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glipizide extended-release tablets, 2.5mg, 30-count bottle Failed Dissolution Specifications. Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064% Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014. Class IIIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Lisinopril tablets, 5 mg, 1000-count bottle Failed tablet/capsule specification: missing break line on the 5mg tablet. Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC… Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity. Class IIFDA’s classFeb 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Olanzapine tablets, USP, 2.5 mg Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month… Class IIIFDA’s classFeb 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL Defective Container: Leakage of unit dose cups that may occur at the seal. Class IIFDA’s classFeb 15, 2017in FDA’s Enforcement Report36 statesnamed in where it went PublishedFeb 15, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medicine recall Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance. Class IIIFDA’s classFeb 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Aripiprazole Tablets, 2 mg, 30-count bottle Superpotent Drug: Product may not meet specifications throughout shelf life. Class IIIFDA’s classFeb 15, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles Failed Dissolution Specifications; 18 month stability time point Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles Failed Dissolution Specifications; 18 month stability time point Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards Failed Dissolution Specifications; 18 month stability time point Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles Failed Dissolution Specifications; 18 month stability time point Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Finasteride Tablets, USP 5 mg, 90-count bottles Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product. Class IIIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedFeb 8, 2017ClassClass IIIStatusTerminatedWhereNew Jersey
- Medicine recall Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4% Subpotent Drug Class IIIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedFeb 8, 2017ClassClass IIIStatusTerminatedWherePuerto Rico
- Medicine recall Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottles (NDC 62756-519-88), b)… Failed Dissolution Specifications Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MIDAZOLAM INJECTION, USP, *25 mg/5 mL Failed Impurities/Degradation Specifications Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL),… CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case. CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per case (NDC No.… CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No.… CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. Class IIFDA’s classFeb 8, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 8, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Furosemide Tablets USP, 20 mg, 1000 count bottles Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz. Failed Impurities/ Degradation Specifications Class IIIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Albuterol Sulfate Inhalation Solution, USP, 0.021% Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. Class IIIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Amoxicillin for Oral Suspension USP, 125 mg per 5 mL Subpotency: due to a low, out of specification test result for assay during stability testing. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedFeb 1, 2017ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Temozolomide Capsules, 100 mg Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Temozolomide Capsules, 140 mg Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Temozolomide Capsules, 180 mg Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Temozolomide Capsules, 250 mg, 5-count bottles Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereNationwide
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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