Browse Drug Recalls

17,897 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,897 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 17,897 FDA drug recalls.

DateProductReasonClassFirm
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 7, 2018 Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Sin... Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty o... Class I Pfizer Inc.
Feb 7, 2018 Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Sin... Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty o... Class I Pfizer Inc.
Feb 7, 2018 BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. ... CGMP Deviations: not manufactured according to current good manufacturing practices. Class III Webrx dba RxPalace.com
Feb 5, 2018 Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canad... Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitt... Class III Genentech, Inc.
Feb 5, 2018 Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, ... Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a fa... Class III Sun Pharmaceutical Industries, Inc.
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 Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Isra... Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily reca... Class III Teva Pharmaceuticals USA
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
Feb 2, 2018 NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, ... Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classificati... Class III ALLERGAN
Feb 2, 2018 Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, M... Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg Class III Aurobindo Pharma Ltd.
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 29, 2018 Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx ... Failed Impurities/Degradations Specifications; out-of-specification results observed for Total De... Class III Dr. Reddy's Laboratories, Inc.
Jan 29, 2018 Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Re... Failed Impurities/Degradations Specifications; out-of-specification results observed for Total De... Class III Dr. Reddy's Laboratories, Inc.
Jan 29, 2018 Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (ND... Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec... Class III Teva Pharmaceuticals USA
Jan 29, 2018 Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-... Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec... Class III Teva Pharmaceuticals USA
Jan 29, 2018 Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (ND... Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec... Class III Teva Pharmaceuticals USA
Jan 29, 2018 Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes o... Subpotent Drug: Out of specification for assay (stability testing) Class III Mckesson Packaging Services
Jan 29, 2018 Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx ... Failed Impurities/Degradations Specifications; out-of-specification results observed for Total De... Class III Dr. Reddy's Laboratories, Inc.

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.