Sapropterin Di recalls

The FDA has published 4 recalls involving Sapropterin Di since 2022. 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 recalls4since 2022

Last 12 months0reported

Class I250% of total

Ongoing3latest 18 Dec 2024

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 1 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 2 50%Class II 0 0%Class III 2 50%

Why sapropterin di is recalled

Potency & Assay4100%

Companies

Dr. Reddy's Laboratories4100%

By year

2024375%
2022125%

Ongoing sapropterin di recalls

3 active

Reported	Class	Recall	Company	Reason	Where
18 Dec 2024Drug	CLASS III	Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
15 May 2024Drug	CLASS I	Javygtor (sapropterin dihydrochloride) Powder recalledJavygtor	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
15 May 2024Drug	CLASS I	Sapropterin Dihydrochloride Powder for Oral Solution 100mg recalled	Dr. Reddy's Laboratories	Potency & Assay	Nationwide

All sapropterin di recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
18 Dec 2024Drug	CLASS III	Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
15 May 2024Drug	CLASS I	Javygtor (sapropterin dihydrochloride) Powder recalledJavygtor	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
15 May 2024Drug	CLASS I	Sapropterin Dihydrochloride Powder for Oral Solution 100mg recalled	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
2 Mar 2022Drug	CLASS III	Sapropterin Dihydrochloride Powder for Oral Solution recalled	Dr. Reddy's Laboratories	Potency & Assay	Nationwide

Should you stop taking Sapropterin Di?

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.