Sodium Phenylbutyrate Powder Recalled for Failed Impurities Specifications
SigmaPharm Laboratories is recalling Sodium Phenylbutyrate powder nationwide due to out-of-specification impurity results found during routine testing. Affected bottles have specific lot numbers and expiration dates ranging from May 2023 to May 2024.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard involves failed impurity specifications detected through routine testing—a quality control issue without documented harm. This qualifies as a moderate-severity precautionary recall under the rubric.
Plain-English summary
SigmaPharm Laboratories LLC is recalling 1,993 bottles of Sodium Phenylbutyrate powder (NDC 42794-086-14) distributed nationwide in the USA. The recall was initiated because routine testing identified out-of-specification impurity results that failed to meet established quality standards.
The affected product is a prescription oral powder supplied in 250-gram bottles. The recall involves multiple lot numbers: 1813001, 1813101, 1813201 (expiring May 2023); 1822601, 1822701 (expiring November 2023); and 1905701, 1905801, 1906501, 1906601, 1906701 (expiring May 2024).
Consumers and healthcare providers in possession of affected bottles should stop use and contact their pharmacy or healthcare provider for guidance. Patients should not discontinue use of this medication without first consulting their healthcare provider, as this drug is used to manage metabolic conditions and requires medical supervision.
The recalled product
- Product
- SODIUM PHENYLBUTYRATE (SODIUM PHENYLBUTYRATE)
- Brand
- SODIUM PHENYLBUTYRATE
- Manufacturer
- SigmaPharm Laboratories LLC
- Category
- Drug — Prescription Oral Powder
- Hazard
- failed-impurity-specs
- out-of-specification-impurity
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- Lot Numbers: 1813001
- 1813101
- 1813201
- EXP. May 2023
- 1822601
- 1822701
- EXP Nov 2023
- 1905701
- 1905801
- 1906501
- 1906601
- 1906701
- EXP May 2024
UPCs (2)
- 0342794086144
- 342794086144
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · SODIUM PHENYLBUTYRATE
- ModerateSodium Phenylbutyrate Powder Recalled for Impurity Specification Failures
FDA (Drugs) · 2021-10-06
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-06-17
- SevereCIMZIA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27