Browse Drug Recalls

3,458 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,458 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 3,458 FDA drug recalls.

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DateProductReasonClassFirm
Nov 14, 2024 Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister ... CGMP Deviations: Released product should have been rejected. Class II LNK International, Inc.
Nov 14, 2024 Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 m... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 14, 2024 safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 o... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 14, 2024 Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit Class II Amerisource Health Services LLC
Nov 14, 2024 Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net C... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 14, 2024 Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (2... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 14, 2024 Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle,... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit Class II Amerisource Health Services LLC
Nov 14, 2024 Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manu... CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... Class II Keystone Industries
Nov 13, 2024 Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By:... CGMP Deviations: lack of adequate release testing. Class II Brands International Corporation
Nov 11, 2024 Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, ... cGMP Deviations: Observations were made that some blister card-foils were separating from the bli... Class II Safecor Health, LLC
Nov 11, 2024 Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box,... cGMP Deviations: Observations were made that some blister card-foils were separating from the bli... Class II Safecor Health, LLC
Nov 11, 2024 Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose ... cGMP Deviations: Observations were made that some blister card-foils were separating from the bli... Class II Safecor Health, LLC
Nov 11, 2024 Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count ... cGMP Deviations: Observations were made that some blister card-foils were separating from the bli... Class II Safecor Health, LLC
Nov 11, 2024 Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit... cGMP Deviations: Observations were made that some blister card-foils were separating from the bli... Class II Safecor Health, LLC
Nov 7, 2024 Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-83... cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Class II Aurobindo Pharma USA Inc
Nov 7, 2024 Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-83... cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Class II Aurobindo Pharma USA Inc
Nov 7, 2024 Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832... cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Class II Aurobindo Pharma USA Inc
Nov 6, 2024 MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallo... cGMP Deviations: Out of specification results for micro in hand soap products. Class II Midlab Incorporated
Nov 6, 2024 Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L),... cGMP Deviations: Out of specification results for micro in hand soap products. Class II Midlab Incorporated
Nov 6, 2024 Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: ... cGMP Deviations: Out of specification results for micro in hand soap products. Class II Midlab Incorporated
Nov 6, 2024 boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L),... cGMP Deviations: Out of specification results for micro in hand soap products. Class II Midlab Incorporated
Nov 6, 2024 Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ... cGMP Deviations: Out of specification results for micro in hand soap products. Class II Midlab Incorporated
Nov 6, 2024 ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ... cGMP Deviations: Out of specification results for micro in hand soap products. Class II Midlab Incorporated
Nov 1, 2024 Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in b... cGMP Deviations Class II JR Watkins
Nov 1, 2024 Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Ca... cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim... Class II Glenmark Pharmaceuticals Inc., USA
Nov 1, 2024 Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dos... cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim... Class II Glenmark Pharmaceuticals Inc., USA
Nov 1, 2024 Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dos... cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim... Class II Glenmark Pharmaceuticals Inc., USA
Nov 1, 2024 Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dos... cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim... Class II Glenmark Pharmaceuticals Inc., USA
Nov 1, 2024 Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 C... cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim... Class II Glenmark Pharmaceuticals Inc., USA
Nov 1, 2024 Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosa... cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim... Class II Glenmark Pharmaceuticals Inc., USA
Oct 24, 2024 HealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per bo... cGMP Deviations Class II Unexo Life Sciences Private Limited
Oct 24, 2024 ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a... cGMP Deviations Class II Unexo Life Sciences Private Limited
Oct 24, 2024 CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distribute... cGMP Deviations Class II Unexo Life Sciences Private Limited
Oct 24, 2024 ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distri... cGMP Deviations Class II Unexo Life Sciences Private Limited
Oct 24, 2024 JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Dist... cGMP Deviations Class II Unexo Life Sciences Private Limited
Oct 24, 2024 EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine 4% Topical A... cGMP Deviations Class II Unexo Life Sciences Private Limited
Oct 24, 2024 LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87... cGMP Deviations Class II Unexo Life Sciences Private Limited
Oct 24, 2024 THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71... cGMP Deviations Class II Unexo Life Sciences Private Limited
Oct 24, 2024 PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.... cGMP Deviations Class II Unexo Life Sciences Private Limited
Oct 24, 2024 ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box... cGMP Deviations Class II Unexo Life Sciences Private Limited
Oct 24, 2024 THERACARE Cold Hot Medicated Patch, Menthol 5%, 5 patches per box, Manufactur... cGMP Deviations Class II Unexo Life Sciences Private Limited
Oct 23, 2024 Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC ... CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor Class II Lupin Pharmaceuticals Inc.
Oct 23, 2024 Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count ND... CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor Class II Lupin Pharmaceuticals Inc.
Oct 23, 2024 Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC... CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor Class II Lupin Pharmaceuticals Inc.
Oct 15, 2024 OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Lax... CGMP Deviations Class II Akron Pharma, Inc.
Oct 10, 2024 Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-1... CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... Class II ACCORD HEALTHCARE, INC.
Oct 10, 2024 Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-... CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... Class II ACCORD HEALTHCARE, INC.
Oct 10, 2024 Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, M... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Breckenridge Pharmaceutical, Inc
Oct 10, 2024 Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-... CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... Class II ACCORD HEALTHCARE, INC.
Oct 9, 2024 Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories... CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Class II 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.