CLASS II Drug recall · Reported 1 Sep 2021 · FDA Enforcement Report
Sodium Phenylbutyrate Powder recalled by SigmaPharm Laboratories
SigmaPharm Laboratories is recalling Sodium Phenylbutyrate Powder, distributed nationwide in the US. The recall was initiated on 13 Aug 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0766-2021
- FDA event ID
- 88474
- Recalling firm
- SigmaPharm Laboratories, Bensalem, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Aug 2021
- FDA classified
- 24 Aug 2021
- Reported
- 1 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 13 Aug 2021 | Recall initiated by company | |
| 24 Aug 2021 | Classified by FDA | +11 days |
| 1 Sep 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4
Where it was distributed
Disttibuted Nationwide in the USA.
Questions about this recall
Is Sodium Phenylbutyrate Powder recalled?
Yes. SigmaPharm Laboratories recalled Sodium Phenylbutyrate Powder on 13 Aug 2021. The recall is Class II and its status is Terminated. Recall number D-0766-2021.
Why was it recalled?
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Which lots are affected?
Lot Numbers: 1813001, 1813101, 1813201, EXP. May 2023; 1822601, 1822701, EXP Nov 2023; 1905701, 1905801, 1906501, 1906601, 1906701, EXP May 2024
Where was it sold?
Disttibuted Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from SigmaPharm Laboratories
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sodium Phenylbutyrate Powder recalled by SigmaPharm Laboratories | SigmaPharm Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Asenapine Sublingual Tablets, 10 mg recalled by SigmaPharm LaboratoriesAsenapine | SigmaPharm Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS III | Asenapine Sublingual Tablets, 5 mg recalled by SigmaPharm LaboratoriesAsenapine | SigmaPharm Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS II | Liothyronine Sodium Tablets, USP 5 mcg recalledLiothyronine Sodium | SigmaPharm Laboratories | Other | Nationwide |
Other Sodium phenylbutyrate recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sodium Phenylbutyrate Powder recalled by SigmaPharm Laboratories | SigmaPharm Laboratories | Potency & Assay | Nationwide |