Browse Drug Recalls
14,449 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,449 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 14,449 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29... | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... | Class II | Keystone Industries |
| Nov 14, 2024 | Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use... | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... | Class II | Keystone Industries |
| Nov 14, 2024 | Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Glut... | 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 | Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada. | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... | Class II | Keystone Industries |
| Nov 14, 2024 | M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 ... | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of th... | Class II | Keystone Industries |
| 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 | Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml... | 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, 20 mg, Rx only, 60 count bottles, M... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit | Class II | Amerisource Health Services LLC |
| Nov 14, 2024 | Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 m... | 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 | 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 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 | 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 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 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 | 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, 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 | 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 | 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 | 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 | 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 | 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 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 | BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syr... | Lack of Sterility Assurance | Class II | Tailstorm Health INC |
| 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 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 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 | 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 | 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 | THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71... | cGMP Deviations | Class II | Unexo Life Sciences Private Limited |
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.