Browse Drug Recalls

14,136 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,136 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 14,136 FDA drug recalls — Class II.

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DateProductReasonClassFirm
Nov 11, 2024 Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/... Presence of Particulate Matter: Potential for glass delamination from the vials. Class II American Regent, Inc.
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 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 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 11, 2024 Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/m... Presence of Particulate Matter: Potential for glass delamination from the vials. Class II American Regent, Inc.
Nov 11, 2024 Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/m... Presence of Particulate Matter: Potential for glass delamination from the vials. Class II American Regent, Inc.
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 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 8, 2024 Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx O... Subpotent drug Class II ACCORD HEALTHCARE, 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 7, 2024 Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceutic... Failed Impurity/Degradation Specifications Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Nov 7, 2024 Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceutica... Failed Impurity/Degradation Specifications Class II The Harvard Drug Group LLC dba Major Pharmaceut...
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 6, 2024 Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gol... Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared a... Class II Trinity Gold Nutrition
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 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 BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syr... Lack of Sterility Assurance Class II Tailstorm Health INC
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 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 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 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
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 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
Oct 31, 2024 Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 ... Defective Delivery System: The product does not meet predetermined specifications for Coldflow (a... Class II Noven Pharmaceuticals Inc
Oct 30, 2024 Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled S... Labeling: Missing Label Class II Baxter Healthcare Corporation
Oct 29, 2024 Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences ... Crystallization Class II VIONA PHARMACEUTICALS INC
Oct 29, 2024 Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,... Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lod... Class II FDC Limited
Oct 25, 2024 Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only... Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified... Class II Lannett Company Inc.
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 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 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 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 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 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 EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine 4% Topical A... cGMP Deviations Class II Unexo Life Sciences Private Limited
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 ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distri... 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 PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a... cGMP Deviations Class II Unexo Life Sciences Private Limited
Oct 23, 2024 Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manuf... Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets. Class II Cipla USA, 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 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 Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manuf... Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets. Class II Cipla USA, 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.