Browse Drug Recalls

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

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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 Biotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (N... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Tacrolimus USP (Monohydrate) for prescription compounding, packaged in a) 1g ... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Ketamine HCl 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 Methylcobalamin (Vitamin B12) for prescription compounding, packaged in a) 50... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Clonidine HCl USP for prescription compounding, packaged in a) 5g (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 Nandrolone Decanoate USP for prescription compounding, packaged in a) 25g (ND... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Tretinoin USP for prescription compounding, packaged in a) 5g (NDC 58597-803... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only, p... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Cyanocobalamin USP (Vitamin B12) 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 Stanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-85... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 5... Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Tors... Class II Apace KY LLC
Feb 9, 2018 Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed ... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Leucovorin Calcium USP for prescription compounding, packaged a) 100mg, (NDC... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Diclofenac Sodium USP for prescription compounding, packaged in a) 25g (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 Liothyronine Sodium USP for prescription compounding ,1g, RX only, packed by... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Gabapentin 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 Levothyroxine Sodium USP for prescription compounding, packaged in a) 1g (NDC... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Medroxyprogesterone Acetate USP (Micronized) for prescription compounding 100... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Pentoxifylline USP for prescription compounding, packaged in a) 25g (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 Flurbiprofen 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 Vancomycin HCl USP for prescription compounding, packaged in a) 25g (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 Naltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Vardenafil HCl USP (trihydrate) 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 Sumatriptan USP for prescription compounding, packaged in 10g (NDC 58597-8089... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Levofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Clindamycin Phosphate USP for prescription compounding, packaged in a) 10g (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 (Soy) (Micronized) USP for prescription compounding, packaged in... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Testosterone Enanthate USP for prescription compounding, packaged in a) 25g (... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Estrone USP for prescription compounding, packaged in a) 5 g (NDC 58597-8049... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Lincomycin 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 5, 2018 0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 25... Lack of assurance of sterility: Three lots were released where there was a failure to follow prop... Class II PharMEDium Services, LLC
Feb 5, 2018 100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe,... Lack of assurance of sterility: Three lots were released where there was a failure to follow prop... Class II PharMEDium Services, LLC
Feb 5, 2018 15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag... Lack of assurance of sterility: Three lots were released where there was a failure to follow prop... Class II PharMEDium Services, LLC
Jan 30, 2018 VELCADE (bortezomib) for injection, 3.5 mg/vial, Reconstitution Information, ... Defective Container: Confirmed reports of loose vial crimps. Class II Millennium Pharmaceuticals Inc.
Jan 25, 2018 PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC... CGMP deviations. Class II PD-Rx Pharmaceuticals, Inc.
Jan 22, 2018 Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Mar... Labeling: Label Error on Declared Strength Class II Astellas Pharma US Inc
Jan 19, 2018 Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm, Roche Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 TAD Glutathione Whitening Kits lyophilized powder for injection, 600 mg vials... Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Saluta Glutathione Whitening kits, packaged in 600 mg, 1200 mg and 1800 mg g... Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Sterilized water for injections BP, 50 x 5 mL plastic ampules, Manufactured i... Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Ling Zhi capsules Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 TP Drug Laboratories Vitamin C ampules Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Relumins Vitamin C Solvent ampules Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Tationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione iniettab... Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg v... Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Tatiomax Gluatathione Whitening kits, 1400mg vials, Made in Japan Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Laennec INJ, Placenta extract (human), 2mL vials, Manufactured by: GCJBP Corp... Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Reiki Glutathione Whitening kits Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [N... CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intende... Class II AMERICAN HEALTH PACKAGING

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.