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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
Apr 28, 2023 EPINEPHrine added to dextrose 5%, 2 mg/250 mL* (8 mcg/mL), 250 mL per bag, Rx... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 oxyTOCIN 20 units added to dextrose 5%/Lactated Ringer's 1,000 mL per bag, Rx... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, Induction 4:1 High Potassium, 30 mEq K, packaged in 41... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, Induction 4:1, High Potassium, 60 mEq K, packaged in 8... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 norepinephrine 4 mg added to dextrose 5% 250 mL*, 16 mcg/mL, 250 mL per bag, ... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 HyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Serv... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 heparin added to 0.9% sodium chloride, 2,500 units/500 mL* (5 units/mL), 500 ... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, Reperfusate No Potassium, packaged in 477.5 mL per bag... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 oxyTOCIN 40 units added to 0.9% sodium chloride 1,000 bag, Rx only, Central A... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, Induction 4:1 in Ringer's, HIGH POTASSIUM, 48 mEq K, p... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 vancomycin added to 0.9% sodium chloride, 1 g/250 mL* (4 mg/mL), 25 250 mL pe... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 HyperLyte CR Injection, 250 mL bag, Rx only, Central Admixture Pharmacy Servi... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 heparin added to 0.9% sodium chloride, 2,500 units/250 mL* (10 units/mL), 250... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 vasopressin 40 units added to 0.9% sodium chloride 100 mL*, 0.4 units/mL*, 10... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Transplant Solution (Plasma-Lyte A), packaged in 165 mL per bag, Rx only, Cen... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Microplegia Solution, MSA/MSG 0.92 Molar with CP2D, packaged in 120 mL per ba... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 EPINEPHrine added to dextrose 5%, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, R... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 vancomycin added to 0.9% sodium chloride, 1.5 g/250 mL* (6 mg/mL), 250 mL per... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, Induction 8:1 High Potassium/low dextrose, 100 mEq K, ... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/Dextrose 10% with CALCI... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with CALCI... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 EPINEPHrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 mcg/mL), 250 mL p... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, Maintenance 4:1 in Ringer's, low potassium, 12 mEq K, ... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with low ca... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4.5%/Dextrose 10% with HEP... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 NORepinephrine added to dextrose 5%, 16 mg/250 mL* (64 mcg/mL), 250 mL per ba... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 potassium phosphate 30 mmole added to 0.9% sodium chloride 500 mL per bag, Rx... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, Induction 8:1 non-enriched, HIGH POTASSIUM, 70 mEq K, ... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 diphenhydrAMINE 50 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial A... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 vancomycin added to 0.9% sodium chloride, 2 g/500 mL* (4 mg/mL), 500 mL per b... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 MSA 7.84% MSG 8.56% (0.92M) Comp. Sol. 1000 ml bag, Rx only, Central Admixtur... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine, 40... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10%, package... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, Maintenance 4:1 Plasma-Lyte/Tromethamine, low potassiu... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 vasopressin 20 units added to 0.9% sodium chloride 100 mL*, 0.2 units/mL*, 10... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 27, 2023 Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets... Labeling: Incorrect or Missing Package Insert Class III Teva Pharmaceuticals USA Inc
Apr 27, 2023 Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets... Labeling: Incorrect or Missing Package Insert Class III Teva Pharmaceuticals USA Inc
Apr 27, 2023 Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets... Labeling: Incorrect or Missing Package Insert Class III Teva Pharmaceuticals USA Inc
Apr 27, 2023 Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets... Labeling: Incorrect or Missing Package Insert Class III Teva Pharmaceuticals USA Inc
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 26, 2023 Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, ... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx O... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intraveno... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TEC... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous U... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manuf... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured b... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, Inc.
Apr 26, 2023 Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Dis... CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Akorn, 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.