Browse Drug Recalls
17,539 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,539 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 17,539 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (N... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Nov 18, 2024 | Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets... | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... | Class I | Endo USA, Inc. |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (ND... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Nov 18, 2024 | Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tab... | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... | Class I | Endo USA, Inc. |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (ND... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (N... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (ND... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (N... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (N... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (N... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (N... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Nov 18, 2024 | Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 ta... | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... | Class I | Endo USA, Inc. |
| Nov 18, 2024 | Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablet... | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... | Class I | Endo USA, Inc. |
| Nov 15, 2024 | Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by... | Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 ... | Class II | Evaric Pharmaceuticals Inc. |
| 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 | 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 | UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323 | cGMP Deviations: the firm initiated a recall after notification from the distributor that product... | Class II | MXBBB |
| 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 14, 2024 | Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-D... | Labeling: Not Elsewhere Classified - Wrong NDC number | Class III | Zydus Pharmaceuticals (USA) Inc |
| 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 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 | 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 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 | 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 | 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 | 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 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 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, 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, 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, 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, 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 | 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 | 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 |
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.