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.

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DateProductReasonClassFirm
Jan 3, 2018 Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, M... Failed Dissolution Specifications: Low out of specification results for dissolution during annual... Class II AVKARE Inc.
Dec 20, 2017 Dry to Normal Skin Starter Kit, Trousse debutante pour peau seche a normale. ... Failed Stability Specifications:stability failure at 12 months, long term RT conditions. Class II Odan Laboratories Ltd
Dec 20, 2017 Day Cream SPF15 Cr¿me de jour FPS 15, { Avobenzone 2%, Octinoxate 7%, Oxyben... Failed Stability Specifications:stability failure at 12 months, long term RT conditions. Class II Odan Laboratories Ltd
Dec 14, 2017 Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg,... Failed Impurities/Degradation Specifications: High out of specification test result for the Moexi... Class II Teva Pharmaceuticals USA
Dec 14, 2017 SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90... Failed Stability Specifications Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Dec 13, 2017 INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx ... Failed Stability Specifications: Product stability testing results did not meet specifications fo... Class II ALLERGAN
Dec 4, 2017 Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, ... Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did ... Class II ALLERGAN
Nov 10, 2017 Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spa... Failed Stability Specifications Class III Bayer HealthCare Pharmaceuticals, Inc.
Nov 3, 2017 bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, R... Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntar... Class III Mylan Pharmaceuticals Inc.
Oct 3, 2017 Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CV... Failed impurities/degradation specifications: Famotodine has an out of specification result for a... Class III Dr. Reddy's Laboratories, Inc.
Oct 2, 2017 Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured ... Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was o... Class II Unichem Pharmaceuticals Usa Inc
Sep 13, 2017 Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distribute... Failed Stability Specifications Class III Vi-Jon, Inc.
Sep 5, 2017 Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aid... Failed Impurities/Degradation Specification; out-of-specification results for individual unknown ... Class III Aidarex Pharmaceuticals LLC
Aug 29, 2017 Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packag... Failed Stability Specifications Class III Amerisource Health Services
Aug 10, 2017 Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Inj... Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds c... Class II Premier Pharmacy Labs Inc
Aug 3, 2017 Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10... Failed Impurities/Degradation Specifications: out-of-specification results obtained for individua... Class III KVK-Tech, Inc.
Aug 2, 2017 Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 3... Failed Moisture Limits: out of specification test results for water content obtained during stabi... Class III Teva Pharmaceuticals USA
Jul 20, 2017 Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for... Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/... Class II Hetero USA Inc
Jun 22, 2017 Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, M... Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 mon... Class III Lupin Pharmaceuticals Inc.
Jun 9, 2017 NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per m... Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the c... Class II Advanced Pharma Inc.
Jun 9, 2017 NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10... Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the c... Class II Advanced Pharma Inc.
Jun 9, 2017 NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Steri... Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the c... Class II Advanced Pharma Inc.
Jun 9, 2017 NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 1... Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the c... Class II Advanced Pharma Inc.
May 31, 2017 Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manuf... Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stab... Class I Teva Pharmaceuticals
May 24, 2017 Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distri... Failed Dissolution Specifications: Low dissolution results were obtained during stability testing Class III Shionogi Inc.
May 24, 2017 Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed b... Presence of foreign substance: The recall was initiated due to black particles being observed whi... Class III Shionogi Inc.
May 24, 2017 PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Man... Failed Dissolution Specifications: Low dissolution results were obtained during stability testing Class III Shionogi Inc.
May 9, 2017 Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Str... Failed Stability Specifications: Out of Specification results obtained for preservative Methylpar... Class III Strides Pharma INC
May 1, 2017 Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment... Failed Impurities/Degradation Specifications: stability testing results did not meet the specific... Class II Allergan Sales, LLC
Apr 27, 2017 Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems pe... Defective Delivery System: Out of specification for peel force from the release liner specificati... Class III Noven Pharmaceuticals, Inc.
Mar 28, 2017 PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL b... Failed Stability Specifications Class III Teva Pharmaceuticals USA
Mar 28, 2017 Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units a... Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability Class II Taro Pharmaceuticals U.S.A., Inc.
Mar 15, 2017 Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68... Failed Dissolution Specifications; 9 month long term stability Class II Zydus Pharmaceuticals USA Inc
Feb 17, 2017 Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per ... Failed Dissolution Specifications: low out of specification dissolution results found during stab... Class III Teva Pharmaceuticals USA
Feb 7, 2017 Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in b... Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and ... Class II G & W Laboratories, Inc.
Feb 7, 2017 Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx... Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at... Class III Actavis Inc
Jan 13, 2017 Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 ... Failed Stability Specifications: confirmed out of specification results obtained during refrigera... Class II AbbVie Inc.
Jan 4, 2017 Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 ... Supotent: Out of Specification result for assay test during routine stability testing. Class III Mckesson Packaging Services
Dec 28, 2016 Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 c... Failed Dissolution Specifications; 18 month stability time point Class II Dr. Reddy's Laboratories, Inc.
Dec 28, 2016 Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 c... Failed Dissolution Specifications; 18 month stability time point Class II Dr. Reddy's Laboratories, Inc.
Dec 28, 2016 Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 co... Failed Dissolution Specifications; 18 month stability time point Class II Dr. Reddy's Laboratories, Inc.
Dec 28, 2016 Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. R... Failed Dissolution Specifications; 18 month stability time point Class II Dr. Reddy's Laboratories, Inc.
Dec 22, 2016 TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for:... Failed Stability Specifications Class III Vintage Pharmaceuticals LLC, DBA Qualitest Phar...
Dec 21, 2016 Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bo... Subpotency: due to a low, out of specification test result for assay during stability testing. Class II Teva Pharmaceuticals USA
Dec 20, 2016 buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count ... Failed Dissolution Specifications; 18 month stability time point Class III Sun Pharmaceutical Industries, Inc.
Dec 20, 2016 buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (ND... Failed Dissolution Specifications; 18 month stability time point Class III Sun Pharmaceutical Industries, Inc.
Dec 6, 2016 INOVA (benzoyl peroxide) 4%, Easy Pad (tocopherol) 5%, For topical use only,... Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed vari... Class III Cipher Pharmaceuticals US LLC
Nov 22, 2016 PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantop... Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point. Class III Pfizer Inc.
Nov 17, 2016 SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5... Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 mon... Class III West-Ward Pharmaceuticals Corp.
Nov 14, 2016 Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60... Failed Stability Specifications; out-of specification value for homogeneity / phase separation. Class II Akorn 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.