Medicines, 2015
Shortlist up to four to read them side by side.
2,020 medicine recalls FDA’s Enforcement Report published in 2015, 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.
2,020of 2,020 medicine recallsshown with your filters
The list
- Medicine recall Meclizine Hydrochloride Tablets, USP, 25 mg Tablets Failed Impurities/Degradation Specifications: Out of specification for impurities. Class IIIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 25, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall ACETYLCYSTEINE 10% OPHTALMIC, 10 mL dropper bottle Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alprostadil (PGE-1), 5 mL Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Betamethasone Combo 10 mL Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Betamethasone Combo PF 2 mL Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Betamethasone SP, 2 mL Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Betamethasone SP PF Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bi-Mix (Papaverine 30 mg/mL, Phentolamine 1 mg/mL), 5 mL Multi-Dose Vial Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Brompheniramine Maleate Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cyclo/PE/Trop PF Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cyclo/PE/Tropic/Ketor Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cyclopent/PE/Tropic 2mL Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dapiprazole (Diluent+Powder) 0.5% Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dex LA 8 (Dexamethasone acetate Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dex Combo (Dexamethasone acetate 8mg/mL, dexamethasone sodium phosphate USP, 4 mg/mL),30 mL Multi-Dose Vial,… Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dexamethasone Sodium Phosphate PF Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ePHEDrine Sulfate PF Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl PF 50 mL Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glycopyrrolate USP ( 1 mg/5 mL), 5 mL Single Use syringe, For IM or IV Injection Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection, Rx only, Compounded by US… Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hyaluronic Acid/Lidocaine PF Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hyaluronic Acid/Lidocaine PF Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hyaluronic Acid/Lidocaine Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hyaluronidase PF Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Choline chloride 50 mg/mL, Inositol 50 mg/mL Cyanocobalamin 1000 mcg/mL, 30 mL Multi-Dose Vial, For Deep IM… Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall L-Cysteine PF Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine 1% PF(100 mg/10 mL),10 mL Single Use Syringe, For IV Injection Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lincomycin/Lidocaine Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MedroxyPROGESTERone/Lidocaine Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylcobalamin Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MethylPREDNISolone Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MethylPREDNISolone PF Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylprednisolone/Lidocaine Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MIC Combo (Methionine 25 mg/mL, Inositol 50 mg/mL, Choline chloride 50 mg/mL, Cyanocobalamin 1000 mcg/mL), 30… Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MIC-Combo, 30 mL Multi-Dose Vial, For Deep IM Injection Only Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine PF (2 mg/2 mL), 2 mL Single Use Vial, For IV or IM Administration, Rx only, Compounded by US… Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neostigmine (5 mg/5 mL), 5 mL Single Use Syringe, For IM, SC or Slow IV Injection, Rx only, Compounded by US… Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Omnipaque 300 Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine 1.5%/ Lidocaine 1%, 1 mL Single Use Vial, For Intracameral Injection Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine 10% PF Ophthalmic Solution, 3 mL dropper bottle, For Topical Ophthalmic Use Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine PF Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine PF Sterile Solution Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pilocarpine (1/16%) Ophthalmic, 15 mL dropper bottle, Rx only, Compounded by US Compounding Pharmacy, Conway,… Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Prednisolone Sodium Phosphate PF Solution Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Succinylcholine Chloride Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone cypionate, USP Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone EO-Pro-Cyp 220 Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on… Class IIFDA’s classNov 25, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2015ClassClass 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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