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
Aug 14, 2020 Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intra... Sub-potent Drug: Out-of-Specification assay results found at 3 month stability testing. Class II Hikma Pharmaceuticals USA Inc.
Aug 10, 2020 Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Ave... Failed Stability Specifications: Out of Specification result for enzyme activity levels noted dur... Class II Sanofi-Aventis U.S. LLC
Aug 3, 2020 Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine ... Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compo... Class III Ultra Seal Corporation
Aug 3, 2020 Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65... Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compo... Class III Ultra Seal Corporation
Jul 29, 2020 Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), ... Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. Class II SCA Pharmaceuticals
Jul 6, 2020 Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx ... Cross contamination with other products - OOS discovered during routine stability testing for hig... Class III SUN PHARMACEUTICAL INDUSTRIES INC
Jun 29, 2020 Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repacka... FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained dur... Class II RemedyRepack Inc.
Jun 16, 2020 Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), ... Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. Class II SCA Pharmaceuticals
May 14, 2020 Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: ... Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-ter... Class III InvaGen Pharmaceuticals, Inc.
May 5, 2020 Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only,... Discoloration: Out-of-specification results for appearance obtained during routine stability test... Class II Mylan Institutional LLC
Apr 24, 2020 Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per un... Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine st... Class III The Harvard Drug Group
Apr 18, 2020 Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Dupl... Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Pol... Class I B. Braun Medical Inc
Apr 15, 2020 Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin... Subpotent Drug: low out of specification (OOS) test result observed in long term stability study. Class II Lupin Pharmaceuticals Inc.
Mar 19, 2020 DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECT... Failed Stability Specifications Class II Jubilant Draximage Inc
Feb 24, 2020 Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous ... Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impuritie... Class III Breckenridge Pharmaceutical, Inc
Feb 20, 2020 Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only,... Failed Dissolution Specifications: Low out of specification dissolution result observed during st... Class II Teva Pharmaceuticals USA
Feb 12, 2020 Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, R... Failed Dissolution Specifications: Low out of specification results observed in dissolution test ... Class II Lupin Pharmaceuticals Inc.
Dec 13, 2019 Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-coun... Failed Dissolution Specifications: High out of specification result observed at stability studies. Class III The Harvard Drug Group
Dec 10, 2019 Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-co... Failed Dissolution Specifications: High out of specification result observed at stability studies. Class III Lupin Pharmaceuticals Inc.
Dec 4, 2019 Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister card... Failed Dissolution Specifications: Low out of specification results obtained during stability tes... Class II American Health Packaging
Nov 4, 2019 Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.... Presence of foreign substance: Brown/black particles found during stability testing. Class II Teva Pharmaceuticals USA, Inc.
Oct 30, 2019 Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceu... Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron con... Class II Avantor Performance Materials Inc
Sep 6, 2019 Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in... Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities de... Class II Torrent Pharma Inc.
Aug 28, 2019 AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Table... Failed Stability Specifications. Class II AVKARE Inc.
Aug 21, 2019 Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufa... Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride... Class III Macleods Pharma Usa Inc
Jul 17, 2019 Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tub... Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of c... Class III Lupin Pharmaceuticals Inc.
Jul 11, 2019 Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspe... Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the a... Class II Tris Pharma Inc.
Jul 9, 2019 Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into ... Failed dissolution specifications : failed results at the 3-month stability time point. Class I Jubilant Cadista Pharmaceuticals, Inc.
Jul 2, 2019 Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025... Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification resu... Class II Lupin Pharmaceuticals Inc.
Jun 21, 2019 ARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ (7... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Anal... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 Dermanak original crema blanqueador (Hydroquinone 2%) Skin Fade Cream, 2 OZ. ... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz (11... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 TUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl,... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 Lid O Creme (Lidocaine HCL 4% and Menthol 1%) Topical Analgesic Cream, 2.5 Oz... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical ... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL, 0.1... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 SORBUGEN NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin),... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 Workvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnic... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 AbeeMed cream (Menthol 1.48% and Histamine DHCL 0.05%), 2 OZ jar, Manufacture... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 ARMY HEALTH Pain Reliever Gel With CURCUMIN (Menthol 3.00%), 0.5 OZ jar, Manu... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain ... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 21, 2019 GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Pheny... CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... Class II Pharma-Natural Inc.
Jun 17, 2019 Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g bo... Failed Stability Specifications: Out of specification for viscosity. Class III Bausch & Lomb
Jun 13, 2019 Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured ... Failed Stability Specifications Class II Baxter Healthcare Corporation
Apr 25, 2019 Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malig... Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during... Class II US Worldmeds LLC
Apr 23, 2019 Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per car... Failed impurities/degradation specification: Out of Specification result for total impurity at 4.... Class III Akorn Inc
Apr 3, 2019 Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufact... Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer) Class III AVKARE 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.