Browse Drug Recalls
777 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 777 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 777 FDA drug recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Feb 27, 2025 | Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL si... | Stability data does not support expiry: the products have the potential to be out of specificatio... | Class II | Amgen, Inc. |
| Feb 27, 2025 | Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx ... | Stability data does not support expiry: the products have the potential to be out of specificatio... | Class II | Amgen, Inc. |
| Feb 25, 2025 | Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Myl... | Failed Dissolution Specifications - low dissolution results | Class II | MYLAN PHARMACEUTICALS INC |
| Feb 25, 2025 | METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-... | Presence of Foreign Tablets/Capsules. | Class II | A-S Medication Solutions LLC |
| Feb 24, 2025 | Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Sol... | Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product s... | Class III | Imprimis NJOF, LLC |
| Feb 24, 2025 | Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35... | Chemical Contamination: Presence of benzene. | Class II | Denison Pharmaceuticals, LLC |
| Feb 24, 2025 | Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured... | Presence of foreign tablets/capsules | Class III | Kowa Pharmaceuticals America |
| Feb 20, 2025 | Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Ca... | Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and... | Class I | One Source Nutrition, Inc, |
| Feb 20, 2025 | PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx O... | Presence of Particulate Matter | Class I | Central Admixture Pharmacy Services, Inc. |
| Feb 18, 2025 | Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, ... | Lack of Assurance of Sterility: due to a quality control process deviation. During an internal qu... | Class II | Turbare Manufacturing |
| Feb 17, 2025 | Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg ... | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syr... | Class II | Safecor Health, LLC |
| Feb 17, 2025 | Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solut... | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syr... | Class II | Safecor Health, LLC |
| Feb 17, 2025 | Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Sin... | Subpotent Drug | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 17, 2025 | Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Suppl... | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syr... | Class II | Safecor Health, LLC |
| Feb 17, 2025 | Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrat... | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syr... | Class II | Safecor Health, LLC |
| Feb 17, 2025 | CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton... | Subpotent Drug | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 17, 2025 | Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral S... | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syr... | Class II | Safecor Health, LLC |
| Feb 14, 2025 | BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and... | Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding. | Class I | CareFusion 213, LLC |
| Feb 13, 2025 | Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose... | Failed Impurities/Degradation Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Feb 13, 2025 | Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide... | Chemical Contamination | Class II | Johnson, S C and Son, Inc |
| Feb 13, 2025 | POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case,... | Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain ... | Class I | ICU Medical, Inc. |
| Feb 13, 2025 | Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose... | Failed Impurities/Degradation Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Feb 13, 2025 | POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container... | Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may... | Class I | ICU Medical, Inc. |
| Feb 13, 2025 | Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxid... | Chemical Contamination | Class II | Johnson, S C and Son, Inc |
| Feb 13, 2025 | Iodo Blanco Iodides, First Aid Antiseptic, Mercury Free, Iodine 2%, First Aid... | Defective Container: broken or leaking bottles. | Class II | World Perfumes Inc. |
| Feb 12, 2025 | ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Steri... | Lack of assurance of sterility and cGMP deviations observed at the manufacturing site. | Class II | Wuxi Medical lnstrument Factory Co., Ltd. |
| Feb 10, 2025 | Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, ne... | Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port. | Class II | Nephron Sterile Compounding Center LLC |
| Feb 7, 2025 | Voriconazole Container Description: voriconazole The product packed in white ... | CGMP Deviations | Class II | Aspen Biopharma Labs Pvt., Ltd. |
| Feb 7, 2025 | Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle | CGMP Deviations | Class II | Aspen Biopharma Labs Pvt., Ltd. |
| Feb 7, 2025 | Bimatoprost NDC# 82187-1001-1 Container description: The product packed in ... | CGMP Deviations | Class II | Aspen Biopharma Labs Pvt., Ltd. |
| Feb 7, 2025 | Alprostadil Container Description: Amber color bottle | CGMP Deviations | Class II | Aspen Biopharma Labs Pvt., Ltd. |
| Feb 7, 2025 | Finasteride NDC# 82187-1003-1 Container Description: The product packed in w... | CGMP Deviations | Class II | Aspen Biopharma Labs Pvt., Ltd. |
| Feb 7, 2025 | Chlorambucil Container Description: The product packed in double self-seal co... | CGMP Deviations | Class II | Aspen Biopharma Labs Pvt., Ltd. |
| Feb 6, 2025 | Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only... | Failed Dissolution Specifications | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Feb 6, 2025 | Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical U... | Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethan... | Class II | Padagis US 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 31, 2025 | Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packag... | Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a... | Class I | Alvogen, Inc |
| Jan 31, 2025 | fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single... | Lack of Assurance of Sterility | Class II | Fagron Compounding Services |
| Jan 31, 2025 | CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, ... | Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lod... | Class II | Direct Rx |
| Jan 30, 2025 | Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablet... | Failed Dissolution Specifications. | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| 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 |
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.