Browse Drug Recalls

71 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 71 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 71 FDA drug recalls.

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DateProductReasonClassFirm
Feb 9, 2018 Ketoconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Verapamil HCl USP for prescription compounding, packaged in a) 100g (NDC 5859... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Doxycycline Hyclate USP for prescription compounding, packaged in a) 25g (NDC... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Levetiracetam USP for prescription compounding, packaged in a) 500g (NDC 5859... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Prilocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 585... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Phentolamine Mesylate USP for prescription compounding, packaged in a) 1g (ND... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, pa... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Oxandrolone USP for prescription compounding, packaged in a) 25g (NDC 58597-0... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Tramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 5... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Duloxetine HCl USP for prescription compounding, packaged in a)100g (NDC 5859... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Estradiol USP (Micronized) (Yam) for prescription compounding, packaged in a)... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Tadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g ... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (N... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Testosterone Cypionate USP (Micronized) for prescription compounding, packag... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Calcipotriene BP (Monohydrate) for prescription compounding, packaged in a) 2... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-80... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Jun 1, 2017 Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged ... Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import ... Class II American Pharmaceutical Ingredients LLC
May 26, 2017 Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500... CGMP Deviations: Lack of quality assurance at the API manufacturer. Class II American Pharmaceutical Ingredients LLC
Apr 17, 2017 ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC:... cGMP Deviations; lack of quality assurance. Class II American Pharmaceutical Ingredients LLC

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.