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
Apr 27, 2023 Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets... Labeling: Incorrect or Missing Package Insert Class III Teva Pharmaceuticals USA Inc
Apr 11, 2023 Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial,... Lack of Assurance of Sterility: Malformed crimped collar seal Class II Sanofi-Aventis U.S. LLC
Mar 29, 2023 Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-d... Failed Impurities/Degradation Specifications: Above the specification limits yielded for related ... Class III SUN PHARMACEUTICAL INDUSTRIES INC
Mar 27, 2023 Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 3... Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A. Class III Teva Pharmaceuticals USA Inc
Mar 17, 2023 Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manuf... Out of specification (OOS) for Spectroscopic Identification test by IR. Class II Ascend Laboratories, LLC
Mar 14, 2023 Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx ... CGMP Deviations: Discoloration Class II Hetero USA Inc
Mar 14, 2023 Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufa... CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Da... Class II Ascend Laboratories, LLC
Mar 14, 2023 Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle,... CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Da... Class II Ascend Laboratories, LLC
Mar 13, 2023 Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manuf... Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus ce... Class I Camber Pharmaceuticals Inc.
Mar 9, 2023 Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured... Failed Content Uniformity Specifications Class III SUN PHARMACEUTICAL INDUSTRIES INC
Feb 24, 2023 Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-... Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed d... Class III Zydus Pharmaceuticals (USA) Inc
Feb 23, 2023 Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride op... Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained fo... Class II Teva Pharmaceuticals USA Inc
Feb 22, 2023 Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, R... CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da... Class II Teva Pharmaceuticals USA Inc
Feb 17, 2023 DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Ph... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Akron Pharma, Inc.
Feb 15, 2023 Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by:... Failed Impurities/Degradation Specifications Class II RISING PHARMACEUTICALS
Feb 8, 2023 Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Redd... Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bot... Class II Dr. Reddy's Laboratories, Inc.
Feb 6, 2023 Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Ma... Sub-Potent Drug: Out of specification for assay at the 24 month interval. Class II Alvogen, Inc
Feb 2, 2023 Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First ai... Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing. Class III Advantice Health, Llc
Jan 31, 2023 Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manuf... Failed Impurities/Degradation Specifications: High Out Of Specification degradation results. Class II BIOCON PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 25 microgram/mL; 6 pouch... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 50 microgram/mL; 6 pouch... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 44 microgram/mL; 6 pouc... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 13 microgram/mL; 6 pouch... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 100 microgram/mL; 6 pouc... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 88 microgram/mL; 6 pouch... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 125 microgram/mL; 6 pou... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 37.5 microgram/mL; 6 pou... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 112 microgram/mL; 6 pouc... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 175 microgram/mL; 6 pou... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 62.5 microgram/mL; 6 pou... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 150 microgram/mL; 6 pouc... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 75 microgram/mL; 6 pouch... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 137 microgram/mL; 6 pouc... Subpotent Drug Class II IBSA PHARMA INC
Jan 30, 2023 TIROSINT - SOL (levothyroxine sodium) Oral Solution, 200 microgram/mL; 6 pouc... Subpotent Drug Class II IBSA PHARMA INC
Jan 17, 2023 Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged... CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to ... Class II Fisher Scientific Co., LLC
Jan 17, 2023 Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 ... CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to ... Class II Fisher Scientific Co., LLC
Jan 13, 2023 Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-c... Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and fai... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 5, 2023 Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for... Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package inse... Class III MACLEODS PHARMA USA, INC
Jan 5, 2023 Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablet... Failed Dissolution Specification Class II Ascend Laboratories, LLC
Jan 5, 2023 Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablet... Failed Dissolution Specification Class II Ascend Laboratories, LLC
Jan 5, 2023 Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablet... Failed Dissolution Specification Class II Ascend Laboratories, LLC
Dec 28, 2022 Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 678... Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on th... Class II Ascend Laboratories, LLC
Dec 28, 2022 Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL V... Presence of Particulate Matter: Customer complaint of dark particles found inside the vial Class II Eugia US LLC
Dec 19, 2022 Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles... Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could ... Class I Spectrum Laboratory Products, Inc.
Dec 19, 2022 Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a va... Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could ... Class I Spectrum Laboratory Products, Inc.
Dec 16, 2022 Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton... Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-coun... Class II Hikma Pharmaceuticals USA Inc.
Dec 16, 2022 Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Auro... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Dec 6, 2022 Advil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottles (UPC 3 05... Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear ... Class I Glaxosmithkline Consumer Healthcare Holdings DB...
Dec 6, 2022 Advil Liqui Gels, Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever ... Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear ... Class I Glaxosmithkline Consumer Healthcare Holdings DB...
Dec 6, 2022 Advil Liqui Gels (minis), Solubilized ibuprofen capsules, 200mg, Pain Relieve... Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear ... Class I Glaxosmithkline Consumer Healthcare Holdings DB...

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.