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.
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
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.
The medication failed impurity tests during routine quality checks, meaning it contains substances that shouldn't be present. This could lead to adverse health effects if the product is used as intended.
Patients prescribed Sodium Phenylbutyrate Powder by a doctor are likely affected. Those using the product without a prescription or without proper medical supervision are at higher risk.
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).
Reach out to SigmaPharm Laboratories LLC at Bensalem, PA 19020 for specific instructions on handling the recalled product.
The recall indicates the product failed impurity tests, so it is not safe to use as intended. Consult your doctor before using any recalled product.
Affected lot numbers are 2005401-2005701 (expiring Feb 2023) and 2101401-2101501 (expiring Feb 2024).
Check the product label for the specific lot numbers listed in the recall notice.
We’ve drafted a message you can send SigmaPharm to request your refund or repair — edit it as you like.
Subject: Recall D-0898-2021 — SigmaPharm SigmaPharm Hello, I own a SigmaPharm that is covered by recall D-0898-2021 from SigmaPharm. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
