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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
Jan 20, 2020 Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufac... Failed Dissolution Specifications: testing revealed low out of specification result in one lot o... Class III Macleods Pharma Usa Inc
Jan 14, 2020 Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Sin... cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a prev... Class II Sun Pharmaceutical Industries, Inc.
Jan 14, 2020 methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only... Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to rec... Class III Hikma Pharmaceuticals USA Inc.
Jan 14, 2020 Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL ... cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a prev... Class II Sun Pharmaceutical Industries, Inc.
Jan 10, 2020 NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatat... Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT... Class II Advanced Accelerator Applications USA, Inc.
Jan 7, 2020 Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Appco Pharma LLC
Jan 7, 2020 Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Appco Pharma LLC
Dec 26, 2019 Sumatriptan Succinate Tablets, 50 mg, packaged in a) 9 (1x9) Unit-of use blis... Failed Impurities/Degradation Specifications; out-of-specification results obtained for related s... Class II Sun Pharmaceutical Industries, Inc.
Dec 26, 2019 Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04. CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II AAA Pharmaceutical, Inc.
Dec 26, 2019 Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01. CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II AAA Pharmaceutical, Inc.
Dec 26, 2019 Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use bliste... Failed Impurities/Degradation Specifications; out-of-specification results obtained for related s... Class II Sun Pharmaceutical Industries, Inc.
Dec 17, 2019 Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Gl... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Glenmark Pharmaceuticals Inc., USA
Dec 17, 2019 Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose ... Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) Class I Hikma Pharmaceuticals USA Inc.
Dec 17, 2019 Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: G... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Glenmark Pharmaceuticals Inc., USA
Dec 17, 2019 Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL... Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) Class II Hikma Pharmaceuticals USA Inc.
Dec 17, 2019 Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: G... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Glenmark Pharmaceuticals Inc., USA
Dec 17, 2019 Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Gl... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Glenmark Pharmaceuticals Inc., USA
Dec 17, 2019 Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: G... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Glenmark Pharmaceuticals Inc., USA
Dec 17, 2019 Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: G... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Glenmark Pharmaceuticals Inc., USA
Dec 2, 2019 Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For... Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution. Class III AuroMedics Pharma LLC
Nov 25, 2019 Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-co... Discoloration: Product complaints of discoloration after reconstitution of vials. Class II AuroMedics Pharma LLC
Nov 20, 2019 Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by... Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bo... Class I AuroMedics Pharma LLC
Nov 20, 2019 Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by:... Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bo... Class I AuroMedics Pharma LLC
Nov 19, 2019 Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma US... Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 coun... Class II AuroMedics Pharma LLC
Nov 15, 2019 Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68... Defective delivery system; product is not foaming or is coming out as liquid. Class III Glenmark Pharmaceuticals Inc., USA
Nov 15, 2019 Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100... Defective delivery system; product is not foaming or is coming out as liquid. Class III Glenmark Pharmaceuticals Inc., USA
Nov 15, 2019 Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topi... Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had... Class III Rising Pharmaceuticals, Inc.
Nov 15, 2019 Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For T... Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had... Class III Rising Pharmaceuticals, Inc.
Nov 12, 2019 Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx... Discoloration; Hazy solution found in one vial instead of a clear solution. Class II AuroMedics Pharma LLC
Nov 11, 2019 Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL... Crystallization: Presence of visible particulate matter. Class III AuroMedics Pharma LLC
Nov 11, 2019 Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, p... Presence of Foreign Substance: Foreign material found inside the vial. Class II AuroMedics Pharma LLC
Nov 11, 2019 Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL S... Crystallization: Presence of visible particulate matter. Class III AuroMedics Pharma LLC
Nov 11, 2019 Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL S... Crystallization: Presence of visible particulate matter. Class III AuroMedics Pharma LLC
Nov 6, 2019 DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed... CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules ... Class II AuroMedics Pharma LLC
Nov 6, 2019 Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed b... CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules ... Class II AuroMedics Pharma LLC
Nov 6, 2019 Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by... CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules ... Class II AuroMedics Pharma LLC
Nov 6, 2019 Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by... CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules ... Class II AuroMedics Pharma LLC
Nov 6, 2019 Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL... CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules ... Class II AuroMedics Pharma LLC
Oct 25, 2019 Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured ... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Novitium Pharma LLC
Oct 25, 2019 Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured b... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Novitium Pharma LLC
Oct 25, 2019 Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured b... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Novitium Pharma LLC
Oct 25, 2019 Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only Manufactured ... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Novitium Pharma LLC
Oct 22, 2019 Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Compan... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, ... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Compa... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sa... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Compa... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Compan... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC

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.