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Browse Drug Recalls

6,220 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,220 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 6,220 FDA drug recalls.

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DateProductReasonClassFirm
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 13, 2023 C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder ... Lack of assurance of sterility. Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Apr 11, 2023 Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial,... Lack of Assurance of Sterility: Malformed crimped collar seal Class II Sanofi-Aventis U.S. LLC
Mar 15, 2023 Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextro... Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. Class II Baxter Healthcare Corporation
Mar 15, 2023 Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Amb... Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. Class II Baxter Healthcare Corporation
Mar 1, 2023 Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL... Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartr... Class II Apotex Corp.
Feb 24, 2023 Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83... Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria. Class I Global Pharma Healthcare Private Limited
Feb 22, 2023 Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 m... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose ... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 m... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 14, 2023 Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31... Non-Sterility Class I Pharmedica USA, LLC
Feb 10, 2023 0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B... Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP ... Class II B. Braun Medical Inc.
Feb 10, 2023 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B.... Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP ... Class II B. Braun Medical Inc.
Feb 8, 2023 Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0... Lack of assurance of sterility: Suspected microbial growth present on external label packaging. Class II Apollo Care
Feb 3, 2023 Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx on... Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus. Class II Leadiant Biosciences, Inc.
Jan 30, 2023 Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Ey... Non-Sterility: FDA analysis found unopened products to have bacterial contamination. Class I Global Pharma Healthcare Private Limited
Jan 30, 2023 Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG i... Non-Sterility: FDA analysis found unopened products to have bacterial contamination. Class I Global Pharma Healthcare Private Limited
Jan 6, 2023 Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syri... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Dec 30, 2022 Prostaglandin (E1) Injection Solution, 10 mcg/ml, packaged in 2.5 mL Multiple... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTAB... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 Prostaglandin (E1) Injection Solution, 25mcg/ml, 2.5 mL Multiple-Dose vials, ... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECT... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial,... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 Prostaglandin (E1) Injection Solution, 40mcg/ml, 2.5 mL Multiple-Dose vials, ... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 Prostaglandin (E1) Injection Solution, 20 mcg/ml, 2.5 mL Multiple-Dose vials,... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, ... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC

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.