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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.

By Dosage Form:
AllTabletsCapsulesInjectables
By Recall Category:
AllContamination / SterilityLabeling / PackagingUndeclared Ingredient
Par Health and Endo USA – Argatroban Injection 250 mg/2.5 mL (100 mg/mL)
Date: 10/14/2026
Brand: Par Health and Endo USA
Product: Argatroban Injection 250 mg/2.5 mL (100 mg/mL)
Company: Par Health USA, LLC
Recall Reason: Presence of particulate matter, identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel
Dosage Form: Injection
Category: Other Recall Issue
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Par Pharmaceutical – Brevital Sodium 500 mg/vial for Injection
Date: 10/09/2026
Brand: Par Pharmaceutical
Product: Brevital Sodium 500 mg/vial for Injection
Company: Par Health
Recall Reason: Presence of particulate matter identified as cellulose
Dosage Form: Injection
Category: Other Recall Issue
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Greenwich – Glutathione Injection
Date: 10/01/2026
Brand: Greenwich
Product: Glutathione Injection
Company: Greenwich Rx
Recall Reason: Potential elevated endotoxin levels
Dosage Form: Injection
Category: Quality / Potency
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ICU Medical LLC – 0.9% Sodium Chloride Injection, USP, 100 mL
Date: 09/21/2026
Brand: ICU Medical LLC
Product: 0.9% Sodium Chloride Injection, USP, 100 mL
Company: Otsuka ICU Medical LLC
Recall Reason: Product mix-up where 0.9% Sodium Chloride Injection, USP overwrap may contain 10 mEq Potassium Chloride Injection
Dosage Form: Injection
Category: Other Recall Issue
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Par Pharmaceutical – Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) for Intravenous Infusion
Date: 09/21/2026
Brand: Par Pharmaceutical
Product: Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) for Intravenous Infusion
Company: Par Health
Recall Reason: Presence of particulate matter identified as cellulose or stopper material
Dosage Form: Injection
Category: Other Recall Issue
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B. Braun – 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container
Date: 09/03/2026
Brand: B. Braun
Product: 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container
Company: B. Braun Medical Inc.
Recall Reason: Presence of particulate matter identified as iron oxide
Dosage Form: Injection
Category: Other Recall Issue
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American Regent, Inc. – Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial
Date: 09/03/2026
Brand: American Regent, Inc.
Product: Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial
Company: American Regent, Inc.
Recall Reason: Presence of particulate matter and lack of sterility assurance
Dosage Form: Injection
Category: Contamination / Sterility
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Baxter – 0.9% Sodium Chloride Injection, USP, 500 mL VIAFLEX Plastic Container
Date: 08/26/2026
Brand: Baxter
Product: 0.9% Sodium Chloride Injection, USP, 500 mL VIAFLEX Plastic Container
Company: Baxter International Inc.
Recall Reason: Potential presence of particulate matter identified as fiberglass in the solution.
Dosage Form: Injection
Category: Other Recall Issue
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Baxter – 70% Dextrose Injection, USP in 2000 mL VIAFLEX Plastic Container
Date: 08/25/2026
Brand: Baxter
Product: 70% Dextrose Injection, USP in 2000 mL VIAFLEX Plastic Container
Company: Baxter International Inc.
Recall Reason: Potential presence of particulate matter identified as stainless steel particles in the solution.
Dosage Form: Injection
Category: Other Recall Issue
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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
View Details View FDA Recall Listings
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