Browse Drug Recalls
142 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 142 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 142 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 13, 2025 | Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manuf... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufa... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 11, 2025 | chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bo... | CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended in... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Feb 28, 2025 | Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 5... | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable inta... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Feb 28, 2025 | Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01... | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable inta... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Feb 28, 2025 | Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: G... | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable inta... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Feb 28, 2025 | Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Gl... | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable inta... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured f... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured f... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured f... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured f... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured ... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured f... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured f... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured f... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured f... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured f... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured ... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured f... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured f... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 29, 2025 | Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured f... | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 22, 2025 | Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) ... | CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 22, 2025 | Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b... | CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Dec 11, 2024 | chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, ... | CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Dec 11, 2024 | chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, M... | CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per... | Class II | Glenmark Pharmaceuticals Inc., USA |
| 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 |
| 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 24, 2024 | Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665... | Defective Delivery System: The dip tube is clogged causing the spray not to work. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 30, 2024 | Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmac... | Subpotent Drug | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jul 31, 2024 | Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count b... | Failed Dissolution Specifications: below specification results | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jul 22, 2024 | Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmar... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jun 28, 2024 | Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 684... | Failed Dissolution Specifications: results below specifications | Class II | Glenmark Pharmaceuticals Inc., USA |
| May 30, 2024 | Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-cou... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| May 30, 2024 | Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-cou... | Failed Dissolution Specifications | Class I | Glenmark Pharmaceuticals Inc., USA |
| May 30, 2024 | Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-cou... | Failed Dissolution Specifications | Class I | Glenmark Pharmaceuticals Inc., USA |
| May 30, 2024 | Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-cou... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| May 13, 2024 | Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-... | CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptab... | Class II | Glenmark Pharmaceuticals Inc., USA |
| May 13, 2024 | Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit... | CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptab... | Class II | Glenmark Pharmaceuticals Inc., USA |
| May 10, 2024 | Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufa... | CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptab... | Class II | Glenmark Pharmaceuticals Inc., USA |
| May 10, 2024 | Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufact... | CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptab... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Apr 17, 2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Do... | Failed Dissolution Specifications | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 26, 2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Do... | Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 4, 2024 | Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill v... | Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol | Class II | Glenmark Pharmaceuticals Inc., USA |
| Nov 7, 2023 | Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: ... | Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen | Class II | Glenmark Pharmaceuticals Inc., USA |
| Nov 7, 2023 | Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glen... | Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen | Class II | Glenmark Pharmaceuticals Inc., USA |
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.