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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
Mar 25, 2020 LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufactur... CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... Class II Teva Pharmaceuticals USA
Mar 23, 2020 Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactu... Failed Dissolution Specifications: Out of specification result during long term testing in Tetrac... Class I Avet Pharmaceuticals, Inc.
Mar 23, 2020 Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactu... Failed Dissolution Specifications: Out of specification result during long term testing in Tetrac... Class I Avet Pharmaceuticals, Inc.
Mar 18, 2020 Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bot... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Auro... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aur... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx ... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed ... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bot... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bot... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: ... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 16, 2020 Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11... Defective Container: Recall is due to breaking and shattering of ampules upon opening Class I Dr. Reddy's Laboratories, Inc.
Mar 16, 2020 Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops ... Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... Class II Glaxosmithkline Consumer Healthcare Holdings
Mar 16, 2020 rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F005... Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... Class II Glaxosmithkline Consumer Healthcare Holdings
Mar 16, 2020 fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare B... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, ... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 ... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe,... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, Fo... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with... Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... Class II Glaxosmithkline Consumer Healthcare Holdings
Mar 16, 2020 Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. A... Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... Class II Glaxosmithkline Consumer Healthcare Holdings
Mar 16, 2020 ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride ... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL B... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, F... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bot... Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... Class II Glaxosmithkline Consumer Healthcare Holdings
Mar 13, 2020 Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by:... CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Prac... Class II Sun Pharmaceutical Industries, Inc.
Mar 13, 2020 Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by:... CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Prac... Class II Sun Pharmaceutical Industries, Inc.
Mar 9, 2020 Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactu... Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of At... Class II Sun Pharmaceutical Industries, Inc.
Mar 5, 2020 Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled ... CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-market... Class II Teva Pharmaceuticals USA
Feb 20, 2020 Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only,... Failed Dissolution Specifications: Low out of specification dissolution result observed during st... Class II Teva Pharmaceuticals USA
Feb 14, 2020 Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 m... Labeling: Incorrect or Missing Lot and/or Expiration date. Class III AAA Pharmaceutical, Inc.
Feb 7, 2020 Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose... Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found ... Class III AuroMedics Pharma LLC
Feb 7, 2020 Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count b... Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cabl... Class II AuroMedics Pharma LLC
Jan 31, 2020 Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, ... cGMP Deviations Class II Zydus Pharmaceuticals USA Inc
Jan 29, 2020 Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufa... Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure... Class III UNICHEM PHARMACEUTICALS USA INC
Jan 28, 2020 Kushim Tablets (Gushim) 45-count packages, Label in foreign language Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin... Class II B AND A TRADING CORPORATION
Jan 28, 2020 Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottl... Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets ... Class III Teva Pharmaceuticals USA
Jan 27, 2020 Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-c... CGMP deviations: Product bottle may be absent of desiccant. Class II Teva Pharmaceuticals USA
Jan 27, 2020 Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured... GMP Deviations: Product bottle may be absent of desiccant. Class II Teva Pharmaceuticals USA
Jan 27, 2020 Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-c... CGMP deviations: Product bottle may be absent of desiccant. Class II Teva Pharmaceuticals USA
Jan 27, 2020 Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured... GMP Deviations: Product bottle may be absent of desiccant. Class II Teva Pharmaceuticals USA
Jan 24, 2020 Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, ... Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitaz... Class III Macleods Pharma Usa Inc
Jan 24, 2020 Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactu... cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API sour... Class II Ascend Laboratories LLC
Jan 22, 2020 Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bo... Failed Dissolution Specifications: low out of specification results for dissolution testing. Class III Ascend Laboratories 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.