Sodium Phenylbutyrate POWDER — Class II drug recall D-0766-2021
Terminated recall by SigmaPharm Laboratories LLC, reported 2021-09-01, distributed nationwide. Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
| Recall number | D-0766-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SigmaPharm Laboratories LLC, Bensalem, PA, United States |
| Recall initiated | 2021-08-13 |
| Classified | 2021-08-24 |
| Reported by FDA | 2021-09-01 |
| Terminated | 2022-09-26 |
| Distributed | Nationwide (US) |
| Quantity | 1,993 bottles |
| Reason classes | specification failure |
| NDC | 42794-0086-14 |
| Lot numbers | 1813001, 1813101, 1813201, 1822601, 1822701, 1905701, 1905801, 1906501, 1906601, 1906701 |
| Expiration dates | 2023-05-20, 2023-11-20, 2024-05-20 |
Product
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
Reason for recall
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0766-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.