Medicines, 2013
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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 6, 2026.
1,376of 1,376 medicine recallsshown with your filters
The list
- Medicine recall Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg) Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for investigational use… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 30, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone) Fast Acting Antacid, 200 mg/200 mg/20 mg,… Defective Container: Product lacks tamper evident breakaway band on cap. Class IIIFDA’s classJan 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 30, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Prednisone tablets, USP, 10mg Presence of Foreign Substance(s); Perrigo has been notified of a recall by the manufacturer of this product, West-Ward Pharmaceuticals. Class IIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug’s metabolite. Class IIIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label. Class IIIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 23, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall CABERGOLINE Tablets, 0.5 mg Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life Class IIIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O Lack of Assurance of Sterility: The product is being recalled because the product label does not state sterile in accordance with 21 CFR Part 200.50(a)(1),… Class IIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Epinephrine Injection USP, 1 mL, USP 1:1000 Presence of Particulates; may contain glass particles Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Synthroid (Levothyroxine Sodium) tablets, 150 mcg Labeling: Error on Declared Strength. Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied Non-Sterility FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 9, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied Non-Sterility FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 9, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied Non-Sterility FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 9, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied Non-Sterility FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 9, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection Lack of Assurance of Sterility Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection,… Lack of Assurance of Sterility Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF Lack of Assurance of Sterility Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clonidine 100 mcg/mL PF, 1mL and 2 mL vials Lack of Assurance of Sterility Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials Lack of Assurance of Sterility Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials Lack of Assurance of Sterility Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials Lack of Assurance of Sterility Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Isovue 200 mg/mL PF and 300 mg/mL PF, Vials Lack of Assurance of Sterility Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine/Dextrose 5%/7.5% PF Lack of Assurance of Sterility Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine 1% PF, 2% PF, and 4% PF Lack of Assurance of Sterility Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Omnipaque 240mg/mL PF, 300mg/mL PF Lack of Assurance of Sterility Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Saline 10% and 3% Lack of Assurance of Sterility Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF Lack of Assurance of Sterility Class IIFDA’s classJan 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Thyro-Tab 0.050 mg. Subpotent; 9-month stability interval Class IIFDA’s classJan 2, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 2, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles Subpotent; 9-month stability interval Class IIFDA’s classJan 2, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 2, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Thyro-Tab 0.075 mg. Subpotent; 9-month stability interval Class IIFDA’s classJan 2, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 2, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles Subpotent; 9-month stability interval Class IIFDA’s classJan 2, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 2, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Levothyroxine Sodium Tablets, USP, 175 mcg Subpotent; 15 month stability Class IIFDA’s classJan 2, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 2, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed) Lack of Assurance of Sterility; container closure issues with the bulk batch. Class IIFDA’s classJan 2, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 2, 2013ClassClass IIStatusTerminatedWhereNo state 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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