Unrated Drug recall · FDA · Published August 13, 2021

SigmaPharm Sodium Phenylbutyrate Powder Recall: Failed Impurities Testing

SigmaPharm recalls specific batches of Sodium Phenylbutyrate powder (Rx only) due to failed impurities testing. Affected lots expire May 2023-Nov 2023. Consumers should contact the manufacturer for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0766-2021Drug SigmaPharm ›

Recall notice

Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.

Take action

Contact the company

Recalling firmSigmaPharm Laboratories LLC3375 Progress Dr · Bensalem, PA 19020-5801

✎ GovInfoNow plain-language explainer

SigmaPharm is recalling certain batches of Sodium Phenylbutyrate powder (250g) that failed impurities testing during routine quality checks. This could pose health risks if the impurities are harmful, though the exact risk isn't specified in the recall notice. Read more at govinfonow.com/recall/35958-sigmapharm-sodium-phenylbutyrate-powder-recall-failed-impurities-testing.

Source Summary by GovInfoNow · govinfonow.com/recall/35958-sigmapharm-sodium-phenylbutyrate-powder-recall-failed-impurities-testing · Updated August 18, 2026 · FDA enforcement record: FDA #D-0766-2021

Cite this page

“SigmaPharm Sodium Phenylbutyrate Powder Recall: Failed Impurities Testing.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35958-sigmapharm-sodium-phenylbutyrate-powder-recall-failed-impurities-testing. Based on FDA recall #D-0766-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0766-2021%22&limit=1).

The FDA announced on Aug. 13, 2021, that SigmaPharm Laboratories LLC voluntarily recalled Sodium Phenylbutyrate POWDER due to failed impurity specifications. The Class II recall affects 1,993 bottles distributed nationwide.

How to tell if you have it

Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only
NDC 42794-086-14
UPC Code# 3 42794 086 14 4
Lot Numbers: 1813001, 1813101, 1813201 (EXP. May 2023); 1822601, 1822701 (EXP Nov 2023); 1905701, 1905801, 1906501, 1906601, 1906701 (EXP May 2024)

The hazard

The recall was issued because out-of-specification impurity results were obtained during routine testing. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show SigmaPharm Laboratories LLC has 3 other recalls on record since 2014-04-22. Other recent recalls of similar products include Sagent Busulfan Injection Recall (2026-05-04), Novadoz Glycopyrrolate Oral Solution Recall (2025-12-15), and OneSource Specialty Pharma Methohexital Sodium Recall (2026-06-07).

How to tell if you have this one

Check for the product name 'Sodium Phenylbutyrate Powder', 250 grams, Rx only. Look for lot numbers 1813001-1906701 and expiration dates May 2023 through May 2024.

Brand
SigmaPharm
Product
Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the lot number and expiration date on the product label to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Disttibuted Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 13 months after the firm started it.

Aug 13, 2021Firm started the recall
Aug 24, 2021FDA classified it Class II
Sep 1, 2021Published in FDA’s Enforcement Report
Sep 26, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/35958-sigmapharm-sodium-phenylbutyrate-powder-recall-failed-impurities-testing">SigmaPharm Sodium Phenylbutyrate Powder Recall: Failed Impurities Testing (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0766-2021 (August 13, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0766-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.