Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sodium Phenylbutyrate POWDER Recalled by SigmaPharm Laboratories LLC Due to Failed Impurities Specifications: Out of Specification impurity results...
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 SigmaPharm Laboratories LLC directly.
Affected Products
Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4
Quantity: 1,993 bottles
Why Was This Recalled?
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About SigmaPharm Laboratories LLC
SigmaPharm Laboratories LLC has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report