Sodium Phenylbutyrate recalls
The FDA has published 2 recalls involving Sodium Phenylbutyrate since 2021. The latest was reported on 6 Oct 2021. Most were for potency & assay. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls2since 2021
Last 12 months0reported
Class I00% of total
Ongoing0latest 6 Oct 2021
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 2 100%Class III 0 0%
Why sodium phenylbutyrate is recalled
Companies
By year
All sodium phenylbutyrate recalls, newest first
2 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sodium Phenylbutyrate Powder recalled by SigmaPharm Laboratories | SigmaPharm Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Sodium Phenylbutyrate Powder recalled by SigmaPharm Laboratories | SigmaPharm Laboratories | Potency & Assay | Nationwide |
Should you stop taking Sodium Phenylbutyrate?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.