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/Degradation 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, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in case packs containing 2 bottles. Sigmapharm Laboratories, LLC, Bensalem, PA 19020, NDC 42794-086-14
Quantity: 1192 bottles
Why Was This Recalled?
Failed Impurities/Degradation 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