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Browse Drug Recalls

17,616 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,616 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 17,616 FDA drug recalls.

DateProductReasonClassFirm
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with **l... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 48 mEq K, Induction 4:1 in Ringer's, High Potassium, I... 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 dextrose 5%/lactated ringers 500 mL, IV Bag, Rx On... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 60 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 norepinephrine, 16 mg, added to dextrose 5% 250 mL, IV Bag, CONCENTRATION 64 ... 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 vancomycin 750 mg/250 mL added to 0.9% Sodium Chloride, (3 mg/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 heparin 2500 units/500mL added to 0.9% sodium chloride 5 units/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 oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, 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, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High P... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 heparin 4000 units/1000mL added to 0.9% sodium chloride, 4 units/mL, IV Bag, ... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 108 mEq K, Induction 8:1, High Potassium, IV Bag, tota... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 NORepinephrine 4 mg/250 mL added to 0.9% sodium chloride 16 mcg/mL, IV Bag, R... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, 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 dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, 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 CARDIOPLEGIA SOLUTION, LEESBURG CARDIOPLEGIA, IV Bag, Total Volume = 1030.2 m... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 heparin 7500 units added to 0.9% sodium chloride 1000mL, CONCENTRATION = 7.5 ... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 vancomycin 1 g/250 mL added to 0.9% sodium chloride, 4 mg/mL, IV Bag, Rx onl... 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 Lactated Ringer's 500 mL, IV Bag, Rx only, Rx only... 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 glycopyrrolate 1 mg/5 mL (0.2 mg/mL), For Anesthesia Use, Syringe, RX ONLY, C... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, IV Bag, tot... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, IV Bag, Total Volume = 1818 mL, CRYSTALLOID INDUCTION,... 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% with CALCI... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION 122 mEq K, Modified St. Thomas Formula 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, 36 mEq K, Induction 4:1, High Potassium/Low tromethami... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 100 mEq K, Induction 8:1, High 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 Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with low c... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 PHENYLephrine, 40mg/250ml, added to 0.9% sodium chloride, IV Bag, Rx Only, Ce... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Ba... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1 non-enriched, Low Potassium,... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 vancomycin 1.5 g/250 mL added to 0.9% sodium chloride, 6 mg/mL, IV Bag, Rx on... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 vancomycin 1.5 g/250mL added to 5% dextrose, 6 mg/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 phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag, Rx Only, C... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1 Plasmalyte, High 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 heparin 5000 units/500mL added to 0.9% sodium chloride, 10 units/mL, IV Bag, ... 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 5% with **low ... 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%, 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) 3.5%/Dextrose 10%, total v... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 13, 2023 Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bot... Presence of Foreign Substance: Metal embedded in a tablet. Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jul 13, 2023 Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil... Lack of Assurance of Sterility Class II New Vitalis Pharmacy LLC dba New Vitalis Pharmacy
Jul 11, 2023 Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, la... Lack of Assurance of Sterility Class II Sagent Pharmaceuticals
Jul 11, 2023 Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For I... Lack of Assurance of Sterility Class II Sagent Pharmaceuticals
Jul 11, 2023 Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd... Lack of Assurance of Sterility Class II Sagent Pharmaceuticals
Jul 11, 2023 Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem... Failed Dissolution Specifications Class II Ascend Laboratories, LLC
Jul 10, 2023 Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515... CGMP Violations- that spaces adjacent to the production area may have been compromised at the tim... Class II New England Life Care, Inc. dba Advanced Compou...
Jul 10, 2023 Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Ph... Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jul 10, 2023 ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Com... CGMP Violations- that spaces adjacent to the production area may have been compromised at the tim... Class II New England Life Care, Inc. dba Advanced Compou...
Jul 10, 2023 SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, A... CGMP Violations- that spaces adjacent to the production area may have been compromised at the tim... Class II New England Life Care, Inc. dba Advanced Compou...
Jul 10, 2023 PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60... CGMP Violations- that spaces adjacent to the production area may have been compromised at the tim... Class II New England Life Care, Inc. dba Advanced Compou...

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.