Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 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 29, 2024 | IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. ... | Failed Tablet/Capsule Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| 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 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 | 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 Cold Hot Medicated Patch, Menthol 5%, 5 patches per box, Manufactur... | 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 | 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 | 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 | JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Dist... | 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 | 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 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 22, 2024 | Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx On... | Failed Impurities/Degradation Specification | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 22, 2024 | Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only,... | Failed Impurities/Degradation Specification | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 21, 2024 | Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Ath... | Superpotent Drug: Stability failure for assay at 6 months test time-point. | Class II | BLI International, Inc. |
| Oct 18, 2024 | Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured f... | Labeling: Label Mix-Up | Class II | AvKARE |
| Oct 18, 2024 | Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for... | Labeling: Label Mix-Up | Class II | AvKARE |
| Oct 17, 2024 | Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Onl... | Subpotent Drug | Class II | Keystone Industries |
| Oct 15, 2024 | OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Lax... | CGMP Deviations | Class II | Akron Pharma, Inc. |
| Oct 11, 2024 | Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Man... | Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity... | Class III | Padagis US LLC |
| 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 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 | 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, 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 9, 2024 | Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratorie... | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Class II | Dr. Reddy's Laboratories, 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. |
| Oct 9, 2024 | Cinacalcet Tablets, 90 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. |
| Oct 8, 2024 | LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) p... | CGMP violations. | Class II | Neogen Corporation |
| Oct 8, 2024 | AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg, | Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... | Class II | C & A Naturistics |
| Oct 8, 2024 | LICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL... | CGMP violations. | Class II | Neogen Corporation |
| Oct 1, 2024 | Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multip... | Failed Impurities/Degradation Specifications. | Class II | ACCORD HEALTHCARE, INC. |
| Sep 30, 2024 | Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only... | Defective Container: Firm received complaints of broken tube at the seal. | Class III | Glenmark Pharmaceuticals Inc., USA |
| Sep 30, 2024 | Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, ... | Presence of Particulate Matter: Presence of glass particulates. | Class I | Staska Pharmaceuticals, Inc. |
| Sep 25, 2024 | Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Singl... | cGMP violations | Class II | Fresenius Kabi Compounding, LLC |
| Sep 25, 2024 | Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Do... | cGMP violations | Class II | Fresenius Kabi Compounding, LLC |
| Sep 25, 2024 | Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin,... | Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal subs... | Class III | Denison Pharmaceuticals, LLC |
| Sep 25, 2024 | Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin... | Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal subs... | Class III | Denison Pharmaceuticals, LLC |
| Sep 25, 2024 | Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Singl... | cGMP violations | Class II | Fresenius Kabi Compounding, LLC |
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.