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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.

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DateProductReasonClassFirm
Sep 9, 2021 Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distribu... Presence of Foreign Substance: Product complaints received for the presence of metal wire in one ... Class II Aurobindo Pharma USA Inc.
Sep 2, 2021 Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed ... Labeling: Incorrect Instructions Class II RISING PHARMACEUTICALS
Aug 27, 2021 Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation On... Lack of Assurance of Sterility Class II Glenmark Pharmaceuticals Inc., USA
Aug 27, 2021 Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufa... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Aug 27, 2021 Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceutic... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Aug 27, 2021 Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manu... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Aug 27, 2021 Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmac... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Aug 27, 2021 Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufa... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Aug 27, 2021 Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactu... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Aug 27, 2021 Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Conta... Lack of Assurance of Sterility Class II Glenmark Pharmaceuticals Inc., USA
Aug 23, 2021 Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g... Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ing... Class II Teligent Pharma, Inc.
Aug 13, 2021 Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by:... Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle Class II Zydus Pharmaceuticals (USA) Inc
Aug 11, 2021 Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India... CGMP Deviations Class II Granules USA, Inc.
Aug 5, 2021 Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx o... Labeling: Not elsewhere classified: Mislabeling Class III Hikma Pharmaceuticals USA Inc.
Aug 3, 2021 Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx O... Superpotent Drug Class I Teligent Pharma, Inc.
Aug 2, 2021 Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for:... Presence of foreign matter Class II Macleods Pharma Usa Inc
Jul 29, 2021 Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx onl... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceutic... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx on... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single us... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials,... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx on... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma,... Defective container: possibility for lack of seal integrity. Class II Teligent Pharma, Inc.
Jul 29, 2021 Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, R... CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) ... Class II Teva Pharmaceuticals USA
Jul 29, 2021 Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vi... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with F... Failed Stability Specification; Out of specification for Osmolarity Class II Novel Laboratories, Inc. d.b.a LUPIN
Jul 29, 2021 Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva ... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, ... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a lam... Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determi... Class III Teligent Pharma, Inc.
Jul 29, 2021 Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx L... Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jul 29, 2021 Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx on... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Tev... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, R... CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) ... Class II Teva Pharmaceuticals USA
Jul 29, 2021 Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, R... CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) ... Class II Teva Pharmaceuticals USA
Jul 29, 2021 Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, p... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, ... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in ... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Ph... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 23, 2021 PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable Int... SubPotent: Out of Specification Class II Professional Disposables International, Inc
Jul 23, 2021 PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Profession... SubPotent: Out of Specification Class II Professional Disposables International, Inc
Jul 23, 2021 PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Pr... SubPotent: Out of Specification Class II Professional Disposables International, Inc
Jul 23, 2021 PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable In... SubPotent: Out of Specification Class II Professional Disposables International, Inc
Jul 23, 2021 PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable Inter... SubPotent: Out of Specification Class II Professional Disposables International, Inc
Jul 23, 2021 PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professiona... SubPotent: Out of Specification Class II Professional Disposables International, Inc
Jul 23, 2021 PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packag... SubPotent: Out of Specification Class II Professional Disposables International, Inc
Jul 20, 2021 Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : ... Marketed without ANDA/NDA approval Class II HIS ENTERPRISE 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.