Browse Drug Recalls

2,151 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,151 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 2,151 FDA drug recalls.

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DateProductReasonClassFirm
Dec 26, 2023 Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorph... Microbial Contamination of Non-Sterile Products Class I Haleon US Holdings LLC
Dec 26, 2023 Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramin... Microbial Contamination of Non-Sterile Products Class I Haleon US Holdings LLC
Dec 21, 2023 Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral Solution, Sugar Fre... MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. Class II Pharma Nobis LLC
Dec 21, 2023 Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can... Chemical Contamination: presence of benzene Class I Insight Pharmaceuticals LLC, a Prestige Consume...
Dec 21, 2023 Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution... MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. Class II Pharma Nobis LLC
Dec 21, 2023 CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Grape Fla... MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. Class II Pharma Nobis LLC
Dec 21, 2023 Good Neighbor Pharmacy, DYE FREE, SUGAR FREE Magnesium Citrate Saline Laxativ... MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. Class II Pharma Nobis LLC
Dec 21, 2023 Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution... MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. Class II Pharma Nobis LLC
Nov 22, 2023 TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET... Chemical Contamination; presence of benzene. Class I Insight Pharmaceuticals Corporation
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.
Oct 18, 2023 Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottle... Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus. Class I VistaPharm LLC
Sep 29, 2023 ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* ... Microbial contamination of Non-Sterile Products Class II Biomic Sciences, LLC dba ION Intelligence of Na...
Sep 29, 2023 Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA Microbial contamination of Non-Sterile Products Class II Biomic Sciences, LLC dba ION Intelligence of Na...
Sep 29, 2023 ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA Microbial contamination of Non-Sterile Products Class I Biomic Sciences, LLC dba ION Intelligence of Na...
Sep 25, 2023 BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufact... Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate d... Class I Scynexis, Inc.
Sep 8, 2023 TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride i... Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis Class I Church & Dwight 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
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 7.5 mEq K, Reperfusate 4:1, low potassium, IV Bag, to... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 vancomycin 1.25 g/250 mL added to 0.9% Sodium Chloride, 5 mg/mL, IV Bag, Rx o... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 70 mEq K, Induction 8:1, non-enriched, High Potassium,... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 30 mEq K, Induction 4:1, High Potassium, IV Bag, total... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with CALCI... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 EPINEPHrine added to dextrose 5%, 4mg/250ml, IV Bag, Rx Only, Central Admixtu... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Cent... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CAL... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 oxyTOCIN 10 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental ... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 oxyTOCIN 15 units added to Lactated Ringer's 250 mL, IV Bag, Rx only, Cental ... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Cardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FO... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 TRANSPLANT SOLUTION, Plasma-Lyte A - 75 ml, MSA/MSG 0.92 Molar -60 ml, dextro... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, This... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 vancomycin 2 g/500 mL added to 0.9% Sodium Chloride, 4 mg/mL, IV Bag, Rx only... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 rocuronium50 mg/5 mL (10 mg/mL), Syringes Rx only, this drug was repackaged b... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10%, total vol... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCI... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 5% with CALCIU... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 vancomycin 1.75g added to 0.9% sodium chloride 500mL, IV Bag, Rx only, Centa... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 neostigmine 5 mg/5mL (1mg/mL) Syringe, Rx only, This drug was repacked by CA... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, R... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 EPINEPHrine 8mg/250ml added to dextrose 5%, 32 mcg/mL, IV Bag, Rx Only, Centr... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 36 mEq K, Maintenance 8:1, low Potassium / low dextros... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, IV B... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 2.5%/Dextrose 10%, total v... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCI... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with **low... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, IV Bag, Total Volume = ... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION 40 mEq K, Warm Induction 4:1 High Potassium, IV Bag, to... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 oxyTOCIN, 20 units added to dextrose 5%/lactated ringers 1000 mL, IV Bag, Rx ... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with CAL... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 PHENYLephrine, 10mg/250ml added to 0.9% sodium chloride, 40mcg/mL, IV Bag, Rx... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 70 mEq K, Modified St. Thomas Formula low potassium, I... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. 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.