Browse Drug Recalls

1,045 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,045 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 1,045 FDA drug recalls.

Clear
DateProductReasonClassFirm
Jun 22, 2018 eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hy... Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity Class II Eb5 Corporation
Jun 15, 2018 Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ra... Subpotency: lower than expected potency result was obtained at the 18 month stability time point. Class III Validus Pharmaceuticals, Inc.
Jun 15, 2018 Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distri... Subpotency: lower than expected potency result was obtained at the 18 month stability time point. Class III Validus Pharmaceuticals, Inc.
Jun 7, 2018 Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 m... Superpotent Drug: Composite assay results obtained during routine stability testing were slightly... Class III Mylan Pharmaceuticals Inc.
May 7, 2018 Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perr... Failed Stability Specifications Class II Perrigo New York
Apr 30, 2018 Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 pa... Failed Stability Specifications Class III Teva Pharmaceuticals USA
Apr 23, 2018 Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx on... Failed Dissolution Specifications. High dissolution results were obtained during stability testing. Class III Mckesson Packaging Services
Apr 23, 2018 Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx On... Failed Dissolution Specifications. High dissolution results were obtained during stability testing. Class III Mckesson Packaging Services
Apr 23, 2018 Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg,... Failed Dissolution Specifications. High dissolution results were obtained during stability testing. Class III Mckesson Packaging Services
Apr 13, 2018 OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box ... Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS... Class III Septodont Inc.
Apr 10, 2018 Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 co... Failed Stability Specifications Class II Pharmalucence, Inc.
Mar 21, 2018 Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne... Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability... Class III Mayne Pharma Inc
Mar 15, 2018 buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles,... Failed Dissolution Specifications; during stability testing Class III InvaGen Pharmaceuticals, Inc.
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

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.