Drug Recall Records

This page shows recent human drug recall alerts sourced from the FDA. It includes current and some previously imported records, but is not a complete historical archive of all past recalls. For full historical data, visit the official FDA Drug Recalls page. Always consult a healthcare professional for medical advice.

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Optimal Balance Pharmacy – Glutathione Injection 200MG/ML (30ML), Multi-Dose Vial
Date: 08/20/2026
Brand: Optimal Balance Pharmacy
Product: Glutathione Injection 200MG/ML (30ML), Multi-Dose Vial
Company: Optimal Balance Pharmacy
Recall Reason: Elevated Endotoxin level
Dosage Form: Injection
Category: Quality / Potency
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B. Braun – Excel® Lactated Ringers Injection, 1000mL
Date: 08/19/2026
Brand: B. Braun
Product: Excel® Lactated Ringers Injection, 1000mL
Company: (B. Braun)
Recall Reason: Presence of particulate matter identified primarily as cellulose cotton fibers, with individual particles also identified as cellulose wood fiber and polystyrene
Dosage Form: Injection
Category: Other Recall Issue
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Fresenius Kabi – Tyenne Injection 400 mg/20 mL vial
Date: 08/11/2026
Brand: Fresenius Kabi
Product: Tyenne Injection 400 mg/20 mL vial
Company: Fresenius Kabi
Recall Reason: Due to Presence of Glass Particles
Dosage Form: Injection
Category: Other Recall Issue
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Fresenius Kabi – Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL
Date: 08/05/2026
Brand: Fresenius Kabi
Product: Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL
Company: Fresenius Kabi
Recall Reason: Due to a label mix-up
Dosage Form: Injection
Category: Labeling / Packaging
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OPTIRAY – OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial (Ioversol Injection 74% 350 mg iodine/ml)
Date: 08/04/2026
Brand: OPTIRAY
Product: OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial (Ioversol Injection 74% 350 mg iodine/ml)
Company: Liebel-Flarsheim Company, LLC
Recall Reason: Presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass
Dosage Form: Injection
Category: Other Recall Issue
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American Regent, Inc. – Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL
Date: 07/27/2026
Brand: American Regent, Inc.
Product: Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL
Company: American Regent, Inc.
Recall Reason: Products were found to contain particulate matter
Dosage Form: Injection
Category: Other Recall Issue
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Long Grove Pharmaceuticals – Cyclophosphamide for Injection
Date: 07/24/2026
Brand: Long Grove Pharmaceuticals
Product: Cyclophosphamide for Injection
Company: Sunny Pharmtech, Inc.
Recall Reason: Presence of particulate matter identified as steel
Dosage Form: Injection
Category: Other Recall Issue
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Baxter – Cefazolin in Dextrose Injection
Date: 07/24/2026
Brand: Baxter
Product: Cefazolin in Dextrose Injection
Company: Baxter International Inc.
Recall Reason: Particulate matter (cardboard) found in the solution.
Dosage Form: Injection
Category: Other Recall Issue
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Aisling – DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL
Date: 05/13/2026
Brand: Aisling
Product: DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL
Company: Sun Pharmaceutical Industries, Inc.
Recall Reason: Presence of glass particles
Dosage Form: Injection
Category: Other Recall Issue
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B. Braun – Lactated Ringer’s Injection, E7500, 1L
Date: 04/28/2026
Brand: B. Braun
Product: Lactated Ringer’s Injection, E7500, 1L
Company: B. Braun Medical Inc.
Recall Reason: Products were found to contain particulate matter in solution
Dosage Form: Injection
Category: Other Recall Issue
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Amneal – Magnesium Sulfate in Water for Injection, USP, 4g/100mL, IV bag
Date: 03/24/2026
Brand: Amneal
Product: Magnesium Sulfate in Water for Injection, USP, 4g/100mL, IV bag
Company: Amneal Pharmaceuticals LLC
Recall Reason: A Magnesium Sulfate in Water for Injection pouch was found to contain an IV bag of Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL.
Dosage Form: Injection
Category: Other Recall Issue
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ICU Medical – 20 mEq Potassium Chloride Injection
Date: 11/03/2025
Brand: ICU Medical
Product: 20 mEq Potassium Chloride Injection
Company: Otsuka ICU Medical LLC
Recall Reason: Potential for Potassium chloride overdose: 20 mEq Potassium Chloride Injection is Mislabeled As 10 mEq Potassium Chloride Injection
Dosage Form: Injection
Category: Labeling / Packaging
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