Class III · Low risk
Javygtor (sapropterin dihydrochloride)
Failed Impurities/Degradation Specifications
Is Sapropterin recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Sapropterin (4 total). Check the affected lots below.
Most common reason: Wrong potency / content (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Sapropterin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Sapropterin recalls on record
none so far in 2026; 4 on record, newest first
Class I · High risk
Sapropterin Dihydrochloride Powder for Oral Solution 100mg
Sub-potent Drug; powder discoloration associated with decreased potency
Class I · High risk
Javygtor (sapropterin dihydrochloride)
Sub-potent Drug; powder discoloration associated with decreased potency
Class III · Low risk
Sapropterin Dihydrochloride Powder for Oral Solution
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
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