Sodium Phenylbutyrate Powder (SigmaPharm) – Impurity Deviation (2021)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
SigmaPharm Laboratories LLC
Lot Codes / Batch Numbers
Lots 2005401, 2005501, 2005601, 2005701, Exp FEB 2023, Lots 2101401, 2101501, Exp FEB-2024
Products Sold
Lots 2005401, 2005501, 2005601, 2005701, Exp FEB 2023; Lots 2101401, 2101501, Exp FEB-2024
SigmaPharm Laboratories LLC is recalling Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps due to Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026