Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
ELCYS (cysteine hydrochloride injection) Recalled by Exela Pharma Sciences LLC Due to Presence of Particulate Matter: Silicone
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Exela Pharma Sciences LLC directly.
Affected Products
ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intravenous Infusion Only, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial: NDC 51754-1007-1; Carton: 51754-1007-3).
Quantity: 38,200 vials
Why Was This Recalled?
Presence of Particulate Matter: Silicone
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Exela Pharma Sciences LLC
Exela Pharma Sciences LLC has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report