Browse Drug Recalls
17,539 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,539 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 17,539 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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, 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 28, 2025 | SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium... | Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus | Class I | Ascent Consumer Products Inc. |
| Jan 28, 2025 | SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP... | Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus | Class I | Ascent Consumer Products Inc. |
| Jan 28, 2025 | SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 m... | Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus | Class I | Ascent Consumer Products Inc. |
| Jan 24, 2025 | Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister car... | CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended a... | Class II | RemedyRepack Inc. |
| Jan 24, 2025 | HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactu... | Failed Impurities/Degradation Specifications | Class II | SKY PACKAGING |
| Jan 24, 2025 | HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only... | Failed Impurities/Degradation Specifications | Class II | SKY PACKAGING |
| Jan 23, 2025 | 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 |
| 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 |
| Jan 21, 2025 | Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 bli... | Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results we... | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| 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 |
| Jan 21, 2025 | Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blist... | Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results we... | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Jan 21, 2025 | Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blist... | Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results we... | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Jan 21, 2025 | Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Phar... | Presence of Particulate Matter. | Class I | Provepharm Inc. |
| Jan 17, 2025 | Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL... | cGMP Deviations: Product intended for quarantine was inadvertently distributed. | Class II | McKesson |
| Jan 17, 2025 | BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% z... | Labeling: Missing Label: The finished product potentially missing the labeling with the drug fac... | Class III | The W.S. Badger Company, Inc. |
| Jan 16, 2025 | Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufacture... | Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet | Class III | Appco Pharma LLC |
| Jan 13, 2025 | Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses ... | CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Dulo... | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Jan 10, 2025 | Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syrin... | Failed Stability Specifications - 12-month stability test result for one of the known peptides is... | Class II | Teva Pharmaceuticals USA, Inc |
| Jan 8, 2025 | babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide ... | Failed stability specifications: during routine stability monitoring quality concerns were identi... | Class II | Johnson, S C and Son, Inc |
| Jan 7, 2025 | Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister card... | Presence of Foreign Tablets/Capsules | Class II | Amerisource Health Services LLC |
| Jan 7, 2025 | Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16... | Superpotent; sodium benzoate preservative | Class III | PAI Holdings, LLC. dba Pharmaceutical Associate... |
| Dec 30, 2024 | Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30)... | CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. | Class II | Rising Pharma Holding, Inc. |
| Dec 30, 2024 | Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bot... | Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottl... | Class II | Granules Pharmaceuticals Inc. |
| Dec 30, 2024 | Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Dis... | CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. | Class II | Rising Pharma Holding, Inc. |
| Dec 30, 2024 | Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000... | CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. | Class II | Rising Pharma Holding, Inc. |
| Dec 27, 2024 | Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vi... | Presence of Particulate Matter: A market complaint was received of a glass piece in the vial. | Class II | Eugia US LLC |
| Dec 23, 2024 | First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla,... | CGMP Deviations; product intended for quarantine was inadvertently distributed | Class II | First Aid Beauty Ltd |
| Dec 23, 2024 | Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Produc... | Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules | Class I | Astellas Pharma US Inc. |
| Dec 23, 2024 | Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx on... | Failed Impurities/Degradation Specifications: Out of specification results observed for the impur... | Class II | Viatris Inc |
| Dec 23, 2024 | Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, ... | Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules | Class I | Astellas Pharma US Inc. |
| Dec 23, 2024 | Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx onl... | Failed Impurities/Degradation Specifications: Out of specification results observed for the impur... | Class II | Viatris Inc |
| Dec 20, 2024 | Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg... | Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved dr... | Class I | ENDO USA, Inc. |
| Dec 20, 2024 | Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only,... | Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug s... | Class II | Lupin Pharmaceuticals Inc. |
| Dec 19, 2024 | Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, ... | Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configur... | Class III | West-Ward Columbus Inc |
| Dec 19, 2024 | ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, ... | Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attach... | Class II | Hikma Injectables USA Inc |
| Dec 19, 2024 | phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx onl... | Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attach... | Class II | Hikma Injectables USA Inc |
| Dec 18, 2024 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only... | CGMP Deviations | Class II | Eugia US LLC |
| Dec 18, 2024 | Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops,... | LABELING: LABEL MIX-UP | Class III | AvKARE |
| Dec 18, 2024 | Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granu... | Failed Dissolution Specifications: Out of specification observed during the accelerated stability... | Class II | Granules Pharmaceuticals Inc. |
| Dec 18, 2024 | Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant... | LABELING: LABEL MIX-UP | Class III | AvKARE |
| Dec 18, 2024 | Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufa... | Non-Sterility | Class I | Alcon Research LLC |
| Dec 17, 2024 | glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) ca... | Failed Dissolution Specifications: | Class II | Amerisource Health Services LLC |
| Dec 16, 2024 | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL... | Defective container: Unable to get the solution out of the bottle as the spike of the cap was lod... | Class II | FDC Limited |
| Dec 16, 2024 | FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Di... | Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with und... | Class I | SHOPPERS- PLAZA |
| Dec 16, 2024 | Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufact... | Failed Impurities/Degradation Specifications | Class III | SOMERSET THERAPEUTICS 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.