Browse Drug Recalls

75 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 75 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 75 FDA drug recalls.

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DateProductReasonClassFirm
Feb 13, 2026 Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Onl... Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification ... Class II AvKARE
Dec 31, 2025 Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per ... Out of specification for dissolution. Class II AvKARE
Nov 18, 2025 Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Phar... Cross Contamination with Other Products Class III Glenmark Pharmaceuticals Inc., USA
Sep 2, 2025 Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0... Failed Content Uniformity Specifications Class II AvKARE
Aug 25, 2025 chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit do... Presence of a foreign substance. Class II AvKARE
Aug 25, 2025 chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dos... Presence of a foreign substance. Class II AvKARE
Jun 26, 2025 Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for:... Failed Impurity/Degradation Specifications Class III AvKARE
Jun 26, 2025 Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for:... Failed Impurity/Degradation Specifications Class III AvKARE
May 13, 2025 Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only,... Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was ... Class II AvKARE
May 9, 2025 Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per car... Failed Dissolution Specifications Class II AvKARE
Apr 23, 2025 Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulos... cGMP deviations and lack of assurance of sterility. Class II BRS Analytical Services, LLC
Apr 23, 2025 Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Pro... cGMP deviations and lack of assurance of sterility. Class II BRS Analytical Services, LLC
Apr 23, 2025 Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing... cGMP deviations and lack of assurance of sterility. Class II BRS Analytical Services, LLC
Apr 23, 2025 Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodiu... cGMP deviations and lack of assurance of sterility. Class II BRS Analytical Services, LLC
Apr 23, 2025 Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromello... cGMP deviations and lack of assurance of sterility. Class II BRS Analytical Services, LLC
Feb 4, 2025 Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, ... Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stabili... Class II AvKARE
Jan 21, 2025 Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Man... Out of Specification for Dissolution Class II AvKARE
Dec 18, 2024 Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops,... LABELING: LABEL MIX-UP Class III AvKARE
Dec 18, 2024 Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant... LABELING: LABEL MIX-UP Class III AvKARE
Dec 4, 2024 Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per cart... Failed Dissolution Specifications Class II AvKARE
Nov 27, 2024 Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE... CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinac... Class II AvKARE
Nov 27, 2024 Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE... CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinac... Class II AvKARE
Nov 27, 2024 Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE... CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinac... 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 18, 2024 Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured f... Labeling: Label Mix-Up Class II AvKARE
Mar 28, 2024 Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cart... Microbial contamination of a non-sterile product: potential Bacillus cereus contamination. Class I AvKARE
Aug 11, 2023 Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 pp... Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsa... Class II AVKARE LLC
Aug 11, 2023 Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NE... Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% ... Class II AVKARE LLC
Jun 13, 2023 Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Ma... Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... Class III AVKARE LLC
Dec 22, 2022 Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Onl... Failed impurities/degradation specifications: Out of specification for unknown impurities. Class II AVKARE LLC
Jul 20, 2022 Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured fo... Labeling: Label Error on Declared Strength Class III AVKARE Inc.
Apr 13, 2022 Meclizine Hydrochloride Tablets, USP, 25 mg, 50-count cartons (5 x10 unit dos... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Dec 21, 2021 SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per... Microbial Contamination of Non-Sterile Product Class I Lohxa, LLC
Jun 9, 2021 Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured... Failed Impurities Specification: Out of specification when measuring the impurity degradant D level. Class III AVKARE Inc.
Dec 7, 2020 Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: A... Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during b... Class II AVKARE Inc.
Dec 7, 2020 TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manuf... Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during b... Class I AVKARE Inc.
Oct 30, 2020 Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bo... Failed Dissolution Specifications Class II AVKARE Inc.
Jun 4, 2020 Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II AVKARE Inc.
Jun 4, 2020 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (ND... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II AVKARE Inc.
May 28, 2020 Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-... Presence of Foreign Substance consistent with granules from desiccant packs used during storage Class III AVKARE Inc.
May 26, 2020 Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured b... Presence of Foreign Substance visually consistent with the silica granules present in the desicca... Class III Jubilant Cadista Pharmaceuticals, Inc.
Jan 7, 2020 Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx On... Failed Impurities/Degradation Specifications: High out of specification results for related compo... Class II AVKARE Inc.
Nov 14, 2019 AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, I... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II AVKARE Inc.
Nov 14, 2019 AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. ... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II AVKARE Inc.
Oct 17, 2019 AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 4229... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II AVKARE Inc.
Oct 17, 2019 AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 4229... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II AVKARE Inc.
Aug 28, 2019 AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Table... Failed Stability Specifications. Class II AVKARE Inc.
Apr 24, 2019 Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC ... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II AVKARE Inc.
Apr 24, 2019 Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC ... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II AVKARE Inc.
Apr 3, 2019 Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufact... Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer) Class III AVKARE Inc.

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.