Browse Drug Recalls

6,322 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,322 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 6,322 FDA drug recalls.

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DateProductReasonClassFirm
Jan 15, 2020 Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 20MCG/3... 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...
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 Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML]... 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 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 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 Deoxycholic Acid Sodium Injection,DEOXYCHOLIC ACID SODIUM 1.67% INJECTABLE, F... 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 Pyridoxine Hydrochloride Injection, PYRIDOXINE HCL 100 MG/ML INJECTABLE, For ... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJ... 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 Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCL... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE Diacetate [10ML]... 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...
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 BUP 40MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 MORPHINE 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 1MG//ML/HYDROM 7MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 3MG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BPC-157 2000 mcg/mL in 5 mL vials Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 20MG/SUF 105MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 30MG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 MORPHINE 6MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 5MG/MORP 10MG/ML INJ in 20 mL syringe 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 MORPHINE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 HYDROMORPHONE 6MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 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 TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713)... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 SUFENTANIL 55.5 MCG/ML IN 18ML INJ in 18 mL syringe Assurance Infusion (713... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 HYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 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 BAC 250MCG/ /FENT 3500MCG/ /MORP 25MG/ML INJ in 20 mL syringe Assurance Infu... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 30MG/ FENT 400MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BAC 200MCG/BUP22MG/CLON210MCG/HYDROM 15MG/SUF800MCG/ML ML INJ in 20 mL syring... 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
Dec 20, 2019 TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ in 1 mL vial Assurance Infusion (713) ... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 TRIMIX FORTE 4 (UA) 30MG/3MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (71... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 HCG 10,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BAC 400MCG/BUP 20MG/HYDROM 15MG/SUF 1000MCG/ML INJ in 20 mL syringe Assuranc... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 LIPO B 25MG/50MG/50MG/1000MCG/ML (10ML VIAL) in 20 mL syringe and 10 mL vial... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 MORPHINE 30MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 5MG/ HYDROM 15MG/ SUF 600MCG/ML (40ML) INJ in 20 mL syringe Assurance In... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 FENT 600MCG/ SUF 800MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 15MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 HYDROM 1MG/MORP 20MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 MORP 20MG/SUF 70MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ in 20 mL syringe Assurance I... 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.