Browse Drug Recalls

1,122 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,122 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 1,122 FDA drug recalls in 2023.

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DateProductReasonClassFirm
Nov 9, 2023 Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 4... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = ... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = ... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentra... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentratio... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL ... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 1... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentrati... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentr... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 8, 2023 Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, h... MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide Class I SUGARMDS LLC
Nov 7, 2023 Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: ... Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen Class II Glenmark Pharmaceuticals Inc., USA
Nov 7, 2023 Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glen... Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen Class II Glenmark Pharmaceuticals Inc., USA
Nov 6, 2023 VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manu... Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicilliu... Class I Bayer Healthcare Pharmaceuticals Inc.
Nov 6, 2023 Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, ... Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone relat... Class III Taro Pharmaceuticals Inc.
Nov 1, 2023 Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#... Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient... Class II Apotex Corp.
Nov 1, 2023 Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, ND... Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient... Class II Apotex Corp.
Nov 1, 2023 Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, ND... Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient... Class II Apotex Corp.
Nov 1, 2023 Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, R... Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules Class II Padagis US LLC
Nov 1, 2023 Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#... Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient... Class II Apotex Corp.
Oct 31, 2023 Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I The Harvard Drug Group LLC dba Major Pharmaceut...
Oct 31, 2023 LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 F... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL)... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (1... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bo... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I The Harvard Drug Group LLC dba Major Pharmaceut...
Oct 31, 2023 LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bot... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Te... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, ... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 30, 2023 V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioAc... Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X i... Class III Grato Holdings, Inc.
Oct 27, 2023 Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card ... Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet wit... Class III NCS Healthcare of Kentucky Inc
Oct 27, 2023 Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distribute... Failed Dissolution Specifications Class II Amneal Pharmaceuticals of New York, LLC
Oct 27, 2023 Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-... Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet wit... Class III NCS Healthcare of Kentucky Inc
Oct 26, 2023 Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, M... Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution wi... Class III VistaPharm LLC
Oct 23, 2023 Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Ma... Failed Dissolution Specifications: Out of specification for dissolution. Class II Glenmark Pharmaceuticals Inc., USA
Oct 23, 2023 Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30... Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of... Class III Glenmark Pharmaceuticals Inc., USA
Oct 23, 2023 Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL uni... Failed Content Uniformity Specifications Class I The Harvard Drug Group LLC dba Major Pharmaceut...
Oct 20, 2023 Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukam... Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac. Class I Botanical Be
Oct 20, 2023 Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in... Subpotent Drug Class III Edenbridge Pharmaceuticals, LLC
Oct 20, 2023 Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only,... Sub-potent Drug: Lower potency than labeled. Class III Zyla Life Sciences US Inc.
Oct 20, 2023 DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4... Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer produc... Class II Omega & Delta Co., Inc.
Oct 20, 2023 Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenz... Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac. Class I Botanical Be
Oct 20, 2023 Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distrib... Failed Impurities/Degradation Specifications. Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 20, 2023 Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distribu... Failed Impurities/Degradation Specifications. Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 20, 2023 Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottle... Failed Viscosity Specifications: Out-of-specification test results for viscosity Class II ITF PHARMA INC
Oct 20, 2023 DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237... Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer produc... Class II Omega & Delta Co., Inc.
Oct 20, 2023 Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 ... Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer produc... Class II Omega & Delta Co., 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.