Sodium Phenylbutyrate Powder — Class II drug recall D-0898-2021
Terminated recall by SigmaPharm Laboratories LLC, reported 2021-10-06, distributed nationwide. Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine te
| Recall number | D-0898-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SigmaPharm Laboratories LLC, Bensalem, PA, United States |
| Recall initiated | 2021-09-21 |
| Classified | 2021-09-30 |
| Reported by FDA | 2021-10-06 |
| Terminated | 2022-09-26 |
| Distributed | Nationwide (US) |
| Quantity | 1,192 bottles |
| Reason classes | specification failure |
| NDC | 42794-0086-14 |
| Lot numbers | 2005401, 2005501, 2005601, 2005701, 2101401, 2101501, FEB-2024 |
| Expiration dates | 2023-02-20 |
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
Reason for recall
Failed Impurities/Degradation 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-0898-2021. 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.