Browse Drug Recalls

1,680 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,680 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 1,680 FDA drug recalls — Class III.

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DateProductReasonClassFirm
Jun 12, 2018 Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 551... Failed Impurities/Degradation Specifications Class III Dr. Reddy's Laboratories, Inc.
Jun 8, 2018 ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualge... Labeling: Incorrect or Missing Lot and/or Exp Date. Class III Qualgen, LLC
Jun 8, 2018 TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Q... Labeling: Incorrect or Missing Lot and/or Exp Date. Class III Qualgen, LLC
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 29, 2018 Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Onl... Resuspension problems: Out of specification for appearance and resuspendability. Class III Pharmaceutical Associates Inc
May 25, 2018 Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant ... Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a... Class III Jubilant Cadista Pharmaceuticals, Inc.
May 24, 2018 Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-coun... Labeling: Missing Label Class III LUPIN SOMERSET
May 4, 2018 T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10.... Subpotent Class III Milbar Laboratories, Inc.
May 4, 2018 Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatolog... Subpotent Class III Milbar Laboratories, Inc.
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 26, 2018 Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473... Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to... Class III Sun Pharmaceutical Industries, Inc.
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 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 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 17, 2018 Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-... Failed Dissolution Specification: Low dissolution outside of specifications Class III Rhodes Pharmaceuticals, L.P.
Apr 13, 2018 Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed... Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement o... Class III Boiron Inc.
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 Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 ... cGMP deviations Class III Pharmedium Services, LLC
Apr 10, 2018 Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00 Presence of Foreign Tablets/Capsules Class III Aidarex Pharmaceuticals LLC
Apr 9, 2018 Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manuf... Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride. Class III LEADIANT BIOSCIENCES, INC
Apr 6, 2018 Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bott... Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisino... Class III Sandoz Incorporated
Mar 29, 2018 24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Pa... Subpotent Drug: Product crystallization with accompanying low out of specification results for ch... Class III Akorn, Inc.
Mar 29, 2018 24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Pa... Subpotent Drug: Product crystallization with accompanying low out of specification results for ch... Class III Akorn, Inc.
Mar 29, 2018 Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-72... Subpotent Drug: Product crystallization with accompanying low out of specification results for ch... Class III Akorn, 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 19, 2018 Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by:... Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One... Class III Glenmark Pharmaceuticals Inc., USA
Mar 19, 2018 Tramadol Hydrochloride 50 mg tablets, 120-count, Rx Only; Distributed by Qual... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Lake Erie Medical & Surgical Supply 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 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 9, 2018 Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), pa... Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its lab... Class III Alva-Amco Pharmacal Companies., Inc.
Mar 9, 2018 Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by:... Failed Impurities/Degradation Specifications: High out of specification results for an impurity. Class III Akorn, 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 5, 2018 Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded ... Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which con... Class III Pine Pharmaceuticals, LLC
Mar 5, 2018 Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5... Failed Impurities/Degradation Specifications Class III Novel Laboratories, Inc.
Mar 5, 2018 Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd.... Failed impurities/degradation specifications: Failure to water content and impurity Class III InvaGen Pharmaceuticals, Inc.
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 28, 2018 Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count... Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to ... Class III Osmotica Pharmaceutical Corp
Feb 23, 2018 Lynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured ... Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polym... Class III AstraZeneca Pharmaceuticals LP
Feb 22, 2018 labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Us... Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indica... Class III SCA Pharmaceuticals, LLC.
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 14, 2018 Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manuf... Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride. Class III LEADIANT BIOSCIENCES, INC
Feb 13, 2018 Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufact... Presence of Foreign Tablets/Capsules Class III Nostrum Laboratories 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 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 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 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.
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
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 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

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.