Browse Drug Recalls

1,032 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,032 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 1,032 FDA drug recalls.

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DateProductReasonClassFirm
Mar 15, 2018 buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC ... Failed Dissolution Specifications; during stability testing Class III InvaGen Pharmaceuticals, Inc.
Mar 8, 2018 E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Ma... Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - met... Class II Bracco Diagnostics Inc.
Mar 8, 2018 Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr.... Failed Stability Specifications:Out-of-specification results observed for viscosity during stabil... Class III Dr. Reddy's Laboratories, Inc.
Mar 7, 2018 Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (... Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expirat... Class II American Pharmaceutical Ingredients LLC
Mar 7, 2018 Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOc... Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is ... Class II Apollo Care
Mar 7, 2018 Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC... Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expirat... Class II American Pharmaceutical Ingredients LLC
Mar 7, 2018 Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag, Rx only, APO... Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is ... Class II Apollo Care
Mar 2, 2018 Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flex... Superpotent and Failed Stability Specifications; out of specification results for assay and water... Class III Renaissance Lakewood, LLC
Feb 26, 2018 RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured ... Failed Stability Specifications Class II Mckesson Packaging Services
Feb 21, 2018 Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Onl... Failed Stability Specification: OOS low viscosity results discovered during retain testing. Class III Akorn, Inc.
Feb 19, 2018 Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufact... cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II Kalchem International, Inc.
Feb 15, 2018 Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOL... Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is ... Class II Apollo Care
Feb 15, 2018 Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOc... Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is ... Class II Apollo Care
Feb 9, 2018 Levocetirizine Dihydrochloride 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 Itraconazole USP (Micronized) 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 Ascorbic Acid 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 Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Progesterone USP (Micronized) (Yam) for prescription compounding, packaged i... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Diphenhydramine HCl USP f (or 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 Ketoprofen USP (Micronized) 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 Anastrozole USP for prescription compounding, packaged in a) 1g ( NDC 58597-8... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Fluticasone propionate USP (Micronized) for prescription compounding, package... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Imiquimod USP for prescription compounding, packaged in a) 1g (NDC 58597-8317... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Estriol 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 Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Testosterone USP (Micronized) (Yam) 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 Lidocaine 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 Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-863... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Cyclosporine 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 Ursodiol USP for prescription compounding, packaged in a) 100g (NDC 58597-80... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Lidocaine USP for prescription compounding, packaged in a) 25g (NDC 58597-801... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Hydroxyprogesterone Caproate USP 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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

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.