# FDA recall D-0898-2021

> **SigmaPharm Laboratories LLC** · Class II · drug recall initiated 2021-09-21.

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0898-2021
- **Recalling firm:** SigmaPharm Laboratories LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-09-21
- **Report date:** 2021-10-06
- **Termination date:** 2022-09-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bensalem, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0898-2021

## Citation

> AI Analytics. FDA recall D-0898-2021. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0898-2021. Source: US FDA. Licensed CC0.

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