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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.