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
Jul 9, 2025 Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only,... CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended ... Class II Ascend Laboratories, LLC
Jul 9, 2025 Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton,... Sub-Potent Drug: Subpotent assay results during stability testing. Class II Imprimis NJOF, LLC
Jul 9, 2025 Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only... CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended ... Class II Ascend Laboratories, LLC
Jul 9, 2025 Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution... Sub-Potent Drug: Subpotent assay results during stability testing. Class III Imprimis NJOF, LLC
Jun 30, 2025 Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, ... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Breckenridge Pharmaceutical, Inc.
Jun 30, 2025 Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, M... Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250m... Class II Dr. Reddy's Laboratories, Inc.
Jun 30, 2025 Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carto... Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule. Class II Cipla USA, Inc.
Jun 27, 2025 Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 milli... Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labele... Class I Sandoz Inc
Jun 27, 2025 Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or ... Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vial... Class I Sandoz Inc
Jun 16, 2025 Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only,... Failed Dissolution Specifications: An out of specification results observed in dissolution test d... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jun 6, 2025 ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church ... Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs. Class I Church & Dwight Inc
Jun 6, 2025 ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Dist... Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs. Class I Church & Dwight Inc
Jun 6, 2025 Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET... Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs. Class I Church & Dwight Inc
Jun 2, 2025 Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100... Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial... Class I Amneal Pharmaceuticals, LLC
May 30, 2025 Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactur... Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsul... Class II Zydus Pharmaceuticals (USA) Inc
May 29, 2025 Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL ... Failed Stability Specifications: Out of specification results for the Color Absorbance test duri... Class II Eugia US LLC
May 27, 2025 Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: T... CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. Class II Torrent Pharma Inc.
May 27, 2025 Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured... CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. Class II Torrent Pharma Inc.
May 23, 2025 Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx... Failed Impurities/Degradation Specifications An out-of-specification result was observed in the r... Class II Ascend Laboratories, LLC
May 23, 2025 Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx... Failed Impurities/Degradation Specifications An out-of-specification result was observed in the r... Class II Ascend Laboratories, LLC
May 23, 2025 Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in... Presence of foreign tablets/capsules. Class II Teva Pharmaceuticals USA, Inc
May 22, 2025 Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com ... cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet dis... Class II Aurobindo Pharma USA Inc
May 19, 2025 Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manuf... Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances t... Class III Glenmark Pharmaceuticals Inc., USA
May 15, 2025 Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bo... OOS results reported for the Dissolution (by UV) test. Class II Glenmark Pharmaceuticals Inc., USA
May 13, 2025 Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count S... Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any ... Class II Zydus Pharmaceuticals (USA) Inc
May 13, 2025 Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count s... Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any ... Class II Zydus Pharmaceuticals (USA) Inc
Apr 21, 2025 Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose... Out-of-Specification test results were obtained in at long term conditions during 3 month's stabi... Class II Eugia US LLC
Apr 21, 2025 Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-d... Out-of-Specification test results were obtained in at long term conditions during 3 month's stabi... Class II Eugia US LLC
Apr 17, 2025 Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), M... Presence of Particulate Matter Class I Amneal Pharmaceuticals, LLC
Apr 10, 2025 Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Singl... cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. Class II Eugia US LLC
Apr 3, 2025 chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles... CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended in... Class II Zydus Pharmaceuticals (USA) Inc
Mar 26, 2025 Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per ... CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-dulox... Class II Breckenridge Pharmaceutical, Inc.
Mar 21, 2025 Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesci... Presence of Foreign Substance: Product complaint received for the presence of foreign material em... Class II Zydus Pharmaceuticals (USA) Inc
Mar 17, 2025 Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactu... Failed dissolution specifications: lower than specifications Class II BIOCON PHARMA INC
Mar 13, 2025 Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufact... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenm... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), ... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenm... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, R... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmar... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: G... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactur... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured ... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmar... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottl... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufact... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottl... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: G... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Mar 13, 2025 Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmar... CGMP Deviations 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.