Browse Drug Recalls

6,274 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,274 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 6,274 FDA drug recalls.

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DateProductReasonClassFirm
Jan 15, 2020 MIC-B12 Injection, MIC-B12 25MG/50MG/50MG/1MG/ML INJECTABLE, For IM Use, Refr... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Glycine Injection,GLYCINE USP 50MG/ML INJECTABLE, For IV, IM Use,30 mL Mult... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Mitomycin-C (PF) Irrigation Solution, MITOMYCIN-C (PF) 0.5 MG/ML PF SYRINGE, ... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Biotin (Vitamin H) Injectable Suspension, BIOTIN 10 MG/ML INJ SUSP, For IM Us... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABL... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate I... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 100,000 IU/ML INJECTAB... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Methionine/Inositol/Choline Injection, METHIONINE/INOSITOL/CHOLINE 25MG/50MG/... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 B-COMPLEX 110 INJECTABLE, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose ... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Lysine Hydrochloride Injection, LYSINE HCL 100MG/ML INJECTABLE, For IV, IM ... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Glutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE For IV, IM Use, Refrig... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Zinc Chloride Injection, ZINC CHLORIDE 10MG/ML INJECTABLE, For IV, IM Use, 3... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Cyanocobalamin Injection, CYANOCOBALAMIN 2000 MCG/ML INJECTABLE, For IV, IM... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Hydroxocobalamin Injection, HYDROXOCOBALAMIN 5MG/ML INJECTABLE, For IV, IM ... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Coenzyme Q10 Injection,COENZYME Q-10 20MG/ML OIL INJ SOLN, For IM Use, 10 mL ... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Testosterone Cypionate/Progesterone Injection, TESTOSTERONE CYP/PROGESTERONE ... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE (PF) [... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Dec 20, 2019 BAC 150 mcg/BUP 2 mg/Hydrom 15 mg/Morp 20 mg/SUF 650 mcg/mL Inj. in 20 mL syr... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 15MG/CLON 600MCG/MORP 30MG/ML (40) INJ in 20 mL syringe Assurance Infusi... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 3.5MG/ HYDROM 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 10MG/HYDROM 10MG/MORP 2MG/SUF 250MCG/ML INJ in 20 mL syringe Assurance I... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 SUFENTANIL 150MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 CLON 800MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 53... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 HYDROMORPHONE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 2.5MG/ CLONI 5MCG/ FENT 200MCG/ SUF 50MCG/ML (40) INJ in 20 mL syringe A... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion (713)... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 MORPHINE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BACLOFEN 2000MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 MORPHINE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 HCG 3000U/1ML INJ in 4 mL vial Assurance Infusion (713)533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 CJC-1295 2000 mcg/Ipamorelin 2000 mcg/mL Inj. in 2 mL vial Assurance Infusio... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 675MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 FENT 900MCG/SUF 210MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 TRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials Assurance Infusion (713) 5... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 5MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BAC 4000MCG /FENT 600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 5... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 TESTOSTERONE CYP 200MG/ML OIL (SESAME) INJ in 10 mL vial Assurance Infusion... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 CLON 100MCG/MORP 12MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BAC 225MCG/ BUP 4.5MG/ CLON 9MCG/ MORP 3MG/ML ML INJ in 20 mL syringe Assuran... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 MORPHINE 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 FENTANYL 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 20MG/CLON 300MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BAC 200MCG/ CLONI 250MCG/ MORP 10MG/ML INJ in 20 mL syringe Assurance Infusi... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 3 mg/MORP 15 mg/mL Inj. in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 40MG/MORP 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 10MG/HYDROM 15MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BAC 15MCG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 QUADMIX FORTE in 1 mL vial Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 7MG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 HCG 1,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.