Browse Drug Recalls

412 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 412 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 412 FDA drug recalls.

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DateProductReasonClassFirm
Jun 23, 2023 Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister... Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. ... Class II Amerisource Health Services LLC
Jun 21, 2023 Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr.... Failed dissolution specification: Out of specification results observed in 24-month long term sta... Class II Dr Reddy's Laboratories Limited
May 30, 2023 Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bo... Failed Dissolution Specifications: Out-of-specification results for dissolution (above specificat... Class II Amneal Pharmaceuticals of New York, LLC
May 9, 2023 buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablet... Failed Dissolution Specifications; during stability testing Class II SUN PHARMACEUTICAL INDUSTRIES INC
Mar 16, 2023 Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (1... Failed Dissolution Specifications: Out of specification dissolution results above specified values. Class II Amerisource Health Services LLC
Jan 27, 2023 Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 T... Failed Dissolution Specification: Out of specification dissolution results at time point zero. Th... Class II Amerisource Health Services LLC
Jan 13, 2023 Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-c... Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and fai... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 11, 2023 Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 10... Failed Dissolution Specifications: This recall is being initiated in support of the recall by the... Class II Amerisource Health Services LLC
Jan 5, 2023 Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablet... Failed Dissolution Specification Class II Ascend Laboratories, LLC
Jan 5, 2023 Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablet... Failed Dissolution Specification Class II Ascend Laboratories, LLC
Jan 5, 2023 Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablet... Failed Dissolution Specification Class II Ascend Laboratories, LLC
Jan 4, 2023 SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx ... Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dis... Class III Intersect ENT, Inc.
Nov 21, 2022 Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 12... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Jul 27, 2022 Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-coun... Failed dissolution specifications. Class II Amneal Pharmaceuticals of New York, LLC
Jul 21, 2022 Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-coun... Failed Dissolution Specifications: below specification limits for dissolution. Class II Teva Pharmaceuticals USA Inc
Jul 21, 2022 Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-coun... Failed Dissolution Specifications: below specification limits for dissolution. Class II Teva Pharmaceuticals USA Inc
Jul 18, 2022 Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: ... Failed dissolution specifications. Class II Jubilant Cadista Pharmaceuticals, Inc.
Jul 18, 2022 Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: J... Failed Dissolution Specifications Class II Jubilant Cadista Pharmaceuticals, Inc.
Jul 13, 2022 Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count ... FAILED DISSOLUTION SPECIFICATIONS Class II Dr. Reddy's Laboratories, Inc.
Jul 13, 2022 Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count ... FAILED DISSOLUTION SPECIFICATIONS Class II Dr. Reddy's Laboratories, Inc.
Jul 7, 2022 Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 6050... Failed dissolution specifications: OOS for dissolution at the 12-month stability time point. Class II Apotex Corp.
Jun 29, 2022 Juice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant ... Failed Dissolution Specifications Class III Eco Lips, Inc
Jun 29, 2022 Juice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, H... Failed Dissolution Specifications Class III Eco Lips, Inc
Jun 27, 2022 Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, D... Failed Dissolution Specifications: Failure occurred during routine stability testing of dissoluti... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jun 14, 2022 Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuti... Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution. Class II Teva Pharmaceuticals USA Inc
Jun 10, 2022 Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufac... Failed Dissolution Specifications: Out of specification test results observed in dissolution test... Class II Lupin Pharmaceuticals Inc.
May 11, 2022 Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in... Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability tes... Class I Teva Pharmaceuticals USA Inc
May 3, 2022 Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apo... Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded th... Class III Apotex Corp.
May 3, 2022 Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsule... Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at... Class III American Health Packaging
Apr 28, 2022 Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx onl... Failed Dissolution Specifications: low out of specification results for dissolution. Class II Viatris Inc
Apr 28, 2022 alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distr... Failed Dissolution Specifications: low out-of-specification dissolution test results observed. Class II Viatris Inc
Apr 15, 2022 Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs o... Failed Dissolution Specifications Class II Dr. Reddy's Laboratories, Inc.
Mar 28, 2022 Preferred Pharmaceuticals, Inc. The Physician's Solution., Lansoprazole Delay... Out of specification results observed in dissolution during long term stability testing. Class II Preferred Pharmaceuticals, Inc.
Mar 23, 2022 Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 5... Failed Dissolution Specifications; during long term stability testing. Class II Dr. Reddy's Laboratories, Inc.
Mar 23, 2022 Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, ... Failed Dissolution Specifications; during long term stability testing. Class II Dr. Reddy's Laboratories, Inc.
Feb 28, 2022 PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 ... Failed Dissolution Specifications Class II The Harvard Drug Group
Jan 18, 2022 Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 ... Failed Dissolution Specification: Dissolution results are below specification limits for the acti... Class II Teva Pharmaceuticals USA
Jan 12, 2022 Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Table... Failed Dissolution Specifications. Class II Ascend Laboratories, LLC
Jan 10, 2022 Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals US... Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution. Class II Teva Pharmaceuticals USA
Jan 4, 2022 Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedr... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedr... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Rele... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Na... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudo... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrin... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephe... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Exten... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Dec 20, 2021 Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, R... Failed Dissolution Specifications Class II American Health Packaging
Dec 2, 2021 Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufa... Failed Dissolution Specifications Class II Torrent Pharma 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.