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.

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DateProductReasonClassFirm
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.