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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
Sep 1, 2023 TRP Natural Eyes, Eye Lid Relief, Sterile Eye ointment, Homeopathic 0.14 oz (... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 TRP Natural Eyes, Red Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 TRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL O... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per cart... Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged prod... Class III Amerisource Health Services LLC
Sep 1, 2023 TRP Natural Eyes, Eye Lid Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL O... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 TRP Natural Eyes, Aging Eye Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 TRP Natural Eyes, Floaters Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ ... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 TRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL O... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Eac... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Aug 30, 2023 Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL ... Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results Class II VistaPharm LLC
Aug 29, 2023 Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%), packaged in 9... Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packag... Class III RB Health (US) LLC
Aug 26, 2023 Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr.... Non-Sterility Class I Dr. Berne's Whole Health Products
Aug 26, 2023 Dr. Berne's MSM DROPS 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr... CGMP Deviations Class II Dr. Berne's Whole Health Products
Aug 26, 2023 Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr.... CGMP Deviations Class II Dr. Berne's Whole Health Products
Aug 26, 2023 Dr. Berne's MSM MIST 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr.... CGMP Deviations Class II Dr. Berne's Whole Health Products
Aug 26, 2023 Dr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distri... CGMP Deviations Class II Dr. Berne's Whole Health Products
Aug 25, 2023 WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Br... Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenaf... Class I Hua Da Trading, Inc. dba Wefun Inc.
Aug 25, 2023 Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/D... Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets,... Class I Marlex Pharmaceuticals, Inc.
Aug 25, 2023 Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Di... Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets,... Class II Marlex Pharmaceuticals, Inc.
Aug 25, 2023 BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1... Class II CareFusion 213, LLC
Aug 24, 2023 Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL)... CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions dur... Class II Baxter Healthcare Corporation
Aug 23, 2023 Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Rx only, Manufa... Defective Container: slow leakage under the cap Class III Contract Pharmaceuticals Limited Canada
Aug 22, 2023 Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1... Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity T... Class II Sofie Co dba Sofie
Aug 18, 2023 Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF ... Subpotent Drug: Product does not contain SPF that is declared on the label. Class II HUMANRACE
Aug 18, 2023 Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Su... Subpotent Drug: Product does not contain SPF that is declared on the label. Class II HUMANRACE
Aug 17, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIU... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX ... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, tota... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Cent... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volum... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCI... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, P... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 PHENYLephrine, added to 0.9% sodium chloride, 40mg/250ml (160mcg/mL), IV Bag,... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CAL... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repac... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syri... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Ce... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental ... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume ... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 vancomycin added to 0.9% Sodium Chloride, 1.25 g/250 mL (5 mg/mL), 250mL Exce... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 m... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCI... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx O... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 PHENYLephrine, added to 0.9% sodium chloride, 10mg/250ml (40mcg/mL), IV Bag, ... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 PHENYLephrine added to 0.9% sodium chloride, 20mg/250ml (80 mcg/mL), IV Bag, ... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactu... Cross contamination with other products Class III Lundbeck LLC
Aug 17, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5% / Dextrose 10% with *... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, 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.