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Unrated Drug recall · FDA · Published September 21, 2021

SigmaPharm Sodium Phenylbutyrate Powder Recall: Impurity Risk in Rx Only Medication

SigmaPharm recalls 250g Sodium Phenylbutyrate Powder (Rx only) due to failed impurity tests. Products with specific lot numbers and expiration dates may pose safety risks. 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-0898-2021DrugSigmaPharm ›
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Contact the company

Recalling firmSigmaPharm Laboratories LLC3375 Progress Dr · Bensalem, PA 19020-5801
✎ GovInfoNow plain-language explainer

SigmaPharm is recalling 250-gram Sodium Phenylbutyrate Powder (prescription-only) because routine testing found impurities that don't meet safety standards. This could affect medication safety for patients using the product. Read more at govinfonow.com/recall/35848-sigmapharm-sodium-phenylbutyrate-powder-recall-impurity-risk-in-rx-only.

Source Summary by GovInfoNow · govinfonow.com/recall/35848-sigmapharm-sodium-phenylbutyrate-powder-recall-impurity-risk-in-rx-only · Updated August 18, 2026 · FDA enforcement record: FDA #D-0898-2021

Cite this page

“SigmaPharm Sodium Phenylbutyrate Powder Recall: Impurity Risk in Rx Only Medication.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35848-sigmapharm-sodium-phenylbutyrate-powder-recall-impurity-risk-in-rx-only. Based on FDA recall #D-0898-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0898-2021%22&limit=1).

The FDA announced on September 21, 2021, that SigmaPharm Laboratories LLC voluntarily recalled Sodium Phenylbutyrate Powder due to failed impurity specifications. The recall affects 1,192 bottles distributed nationwide.

How to tell if you have it

  • Brand: SigmaPharm
  • Product: Sodium Phenylbutyrate Powder, 250 Grams, Rx Only
  • Packaging: 500 cc HDPE bottles and 53 mm CRC caps in cartons/case packs of 2
  • NDC: 42794-086-14
  • Lots: 2005401, 2005501, 2005601, 2005701 (Exp FEB 2023); 2101401, 2101501 (Exp FEB-2024)
  • Distribution: Nationwide

The hazard

The product failed impurity specifications 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 OneSource Specialty Pharma Methohexital Sodium Recall (2026-06-07), Ajanta Pharma Fluphenazine Tablets Recall (2026-08-25), and Sagent Busulfan Injection Recall (2026-05-04).

How to tell if you have this one

Check for the product name 'Sodium Phenylbutyrate Powder, 250 Grams, Rx Only' with specific lot numbers: 2005401-2005701 (expiring Feb 2023) or 2101401-2101501 (expiring Feb 2024).

  • Brand
    SigmaPharm
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Contact Manufacturer

    Reach out to SigmaPharm Laboratories LLC at Bensalem, PA 19020 for specific instructions on handling the recalled product.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 12 months after the firm started it.

1. Firm started the recall: Sep 21, 202112. FDA classified it Class II: Sep 30, 202123. Published in FDA’s Enforcement Report: Oct 6, 202134. FDA terminated the recall: Sep 26, 2022420212022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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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-0898-2021 (September 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0898-2021 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA