Browse Drug Recalls
2,097 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,097 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 2,097 FDA drug recalls in NJ.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 13, 2025 | Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottl... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: ... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: ... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenma... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count pack... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactur... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactu... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmar... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, R... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), ... | LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium ... | Class I | Dr. Reddy's Laboratories, Inc. |
| Mar 13, 2025 | Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactu... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenma... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Man... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b)... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured b... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: ... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b).... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| 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 |
| Mar 5, 2025 | Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only,... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit. | Class II | Rising Pharma Holding, Inc. |
| Mar 5, 2025 | La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treat... | Chemical Contamination: This recall has been initiated due to detected trace levels of benzene. | Class II | L'Oreal USA |
| Mar 5, 2025 | La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System... | cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific l... | Class II | L'Oreal USA |
| Mar 5, 2025 | La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treat... | cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific l... | Class II | L'Oreal USA |
| Mar 4, 2025 | Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, ... | Cross Contamination | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 4, 2025 | Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, N... | Cross Contamination | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Feb 28, 2025 | Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, ... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Class II | Breckenridge Pharmaceutical, Inc. |
| Feb 28, 2025 | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, ... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Class II | Breckenridge Pharmaceutical, Inc. |
| Feb 28, 2025 | Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, M... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Class II | Breckenridge Pharmaceutical, Inc. |
| 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 |
| 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 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 | Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose... | Failed Impurities/Degradation Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Feb 6, 2025 | Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only... | Failed Dissolution Specifications | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| 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 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 |
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.