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Browse Drug Recalls

64 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 64 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 64 FDA drug recalls.

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DateProductReasonClassFirm
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 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 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 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 Alprostadil (prostaglandin E1) 80 MCG/ML Injectable, For Intracavernosal Use,... 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 AscorbiX (Buffered C) Injection, Ascorbix (50ML) 500MG/ML Injectable, For IV,... 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 Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE ... 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 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 Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJ... Lack of Assurance of Sterility Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jul 12, 2017 Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass ... CGMP Deviations 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.