Sapropterin Dihydrochloride recalls
The FDA has published 2 recalls involving Sapropterin Dihydrochloride since 2024. The latest was reported on 18 Dec 2024. 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 2024
Last 12 months0reported
Class I150% of total
Ongoing2latest 18 Dec 2024
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 1 50%Class II 0 0%Class III 1 50%
Why sapropterin dihydrochloride is recalled
Companies
By year
Ongoing sapropterin dihydrochloride recalls
2 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS I | Javygtor (sapropterin dihydrochloride) Powder recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
All sapropterin dihydrochloride recalls, newest first
2 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS I | Javygtor (sapropterin dihydrochloride) Powder recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
Should you stop taking Sapropterin Dihydrochloride?
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.