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
Feb 27, 2020 Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distri... Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The... Class II Pfizer Inc.
Feb 3, 2020 Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dos... Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects... Class II Pfizer Inc.
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 Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE Diacetate [10ML]... 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 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 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 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 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 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 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 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 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 Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML]... 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 (PF) [... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
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 Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 1,000 IU/ML INJECTABLE... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 MIC-PLUS Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/M... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Testosterone Cypionate Injection,TESTOSTERONE CYP IN GRAPESEED OIL [10ML] 200... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
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 Testosterone Cypionate Injection, TESTOSTERONE CYP IN GRAPESEED OIL [1ML] 200... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Dexamethasone (LA) Injectable Suspension, DEXAMETHASONE LA [10ML] 16MG INJ S... 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 Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 AscorbiX (Buffered C) Injection, Ascorbix (30ML) 500MG/ML Injectable, For IV,... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Cyanocobalamin/Folinic Acid Injection, CYANOCOBALAMIN : FOLINIC ACID 2000 MCG... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Levocarnitine Injection, LEVOCARNITINE 500 MG/ML INJECTABLE, For IV Use, 30 ... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE ... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Selenium Injection, SELENIUM 200MCG/ML INJECTABLE, For IV Use, 30 mL Multi-d... 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 Alprostadil (prostaglandin E1)150 MCG/ML Injectable, For Intracavernosal Use,... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Methylcobalamin Injection, METHYLCOBALAMIN [CD] 10MG/100MG/ML INJECTABLE, For... 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 BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone... 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 Methylcobalamin Injection, METHYLCOBALAMIN 1 MG/ML INJECTABLE, For IV, IM, SC... 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 Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE ... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Glycerin (PF) Injection,GLYCERIN 99% INJECTABLE, For IV Use,10 mL Single-use... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Arginine Hydrochloride Injection, L-ARGININE HCL 100MG/ML INJECTABLE, For ... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Triamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension, TRIA... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 40MCG/3... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Lidocaine HCL (PF) Injection, LIDOCAINE HCL 4% (PF) 40 MG/ML INJECTABLE, For... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 15, 2020 Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE ... 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 Dexpanthenol Injection, DEXPANTHENOL 250 MG/ML INJECTABLE, For IV, IM Use, Sh... 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...

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.