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 4, 2024 | Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufact... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Feb 22, 2024 | Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, ... | Failed Stability Specification: Water determination was found not complying with specification. | Class II | Eugia US LLC |
| Feb 20, 2024 | Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL... | Failed Dissolution Specifications | Class II | Eugia US LLC |
| Feb 20, 2024 | Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial,... | Failed Impurities/Degradation Specifications: Out of specification for organic impurities | Class II | Eugia US LLC |
| Feb 20, 2024 | Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Dis... | Failed Impurities/Degradation Specifications: Out of specification for organic impurities | Class II | Eugia US LLC |
| Feb 15, 2024 | Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial ... | Presence of Particulate Matter | Class I | Eugia US LLC |
| Feb 6, 2024 | Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP uni... | cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Af... | Class II | Mallinckrodt Hospital Products Inc. |
| Feb 6, 2024 | Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only... | cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Af... | Class II | Mallinckrodt Hospital Products Inc. |
| Feb 5, 2024 | Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bo... | Failed Dissolution Specifications: Out of specification for dissolution. | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Feb 2, 2024 | Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This pac... | Subpotent Drug: Out of specification for assay | Class II | Bausch Health Companies, Inc. |
| Jan 25, 2024 | Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic reg... | Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets. | Class III | Teva Pharmaceuticals USA, Inc |
| Jan 25, 2024 | Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in... | Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets. | Class III | Teva Pharmaceuticals USA, Inc |
| Jan 18, 2024 | Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hou... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun ... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy'... | Misprint on tablet | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 18, 2024 | Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, ... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, D... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distr... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun ... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablet... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy'... | Misprint on tablet | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 18, 2024 | Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets ... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distri... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 16, 2024 | Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of... | Failed Impurities/Degradation Specification: Out of specification for organic impurities | Class II | Ascend Laboratories, LLC |
| Jan 8, 2024 | Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactu... | Failed Dissolution Specifications | Class II | Teva Pharmaceuticals USA, Inc |
| Jan 4, 2024 | Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill v... | Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jan 2, 2024 | Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's ... | Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets. | Class II | Dr. Reddy's Laboratories, Inc. |
| Dec 29, 2023 | buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bo... | Presence of Foreign Tablets/Capsules | Class II | Rising Pharma Holding, Inc. |
| Dec 29, 2023 | Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: St... | Failed Dissolution Specifications | Class II | Strides Pharma Inc. |
| Dec 29, 2023 | Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle... | Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an ... | Class II | Ascend Laboratories, LLC |
| Dec 26, 2023 | Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorph... | Microbial Contamination of Non-Sterile Products | Class I | Haleon US Holdings LLC |
| Dec 26, 2023 | Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramin... | Microbial Contamination of Non-Sterile Products | Class I | Haleon US Holdings LLC |
| Dec 15, 2023 | Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr... | Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tac... | Class II | Dr. Reddy's Laboratories, Inc. |
| Dec 4, 2023 | Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distribute... | Failed Impurities/Degradation Specifications | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Nov 22, 2023 | SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL b... | Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals | Class I | Novartis Pharmaceuticals Corporation |
| Nov 22, 2023 | buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets... | Failed Dissolution Specifications | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Nov 10, 2023 | Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose pack... | OOS for viscosity | Class III | Teva Pharmaceuticals USA, Inc |
| Nov 7, 2023 | Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: ... | Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen | Class II | Glenmark Pharmaceuticals Inc., USA |
| Nov 7, 2023 | Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glen... | Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen | Class II | Glenmark Pharmaceuticals Inc., USA |
| Nov 6, 2023 | VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manu... | Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicilliu... | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 23, 2023 | Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Ma... | Failed Dissolution Specifications: Out of specification for dissolution. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Oct 23, 2023 | Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30... | Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of... | Class III | Glenmark Pharmaceuticals Inc., USA |
| Oct 20, 2023 | Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in... | Subpotent Drug | Class III | Edenbridge Pharmaceuticals, LLC |
| Oct 20, 2023 | Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distrib... | Failed Impurities/Degradation Specifications. | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 20, 2023 | Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distribu... | Failed Impurities/Degradation Specifications. | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 20, 2023 | Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-cou... | Failed Impurities/Degradation Specifications | Class III | Glenmark Pharmaceuticals Inc., USA |
| Oct 20, 2023 | Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Man... | Failed Dissolution Specifications | Class II | Glenmark Pharmaceuticals Inc., USA |
| Oct 19, 2023 | Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx... | Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolutio... | Class II | Zydus Pharmaceuticals (USA) 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.