FDA Recall D-0485-2024

Dr. Reddy's Laboratories, Inc. · Princeton, NJ

Class I — life-threatening Ongoing 766 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30.

Lot / code: Lot #: T2202812, Exp. 07/31/2025; T2204053, Exp. 10/31/2025; T2300975, T2300976, Exp. 02/28/2026; T2304356, Exp. 08/31/2026.

Quantity: 17,332 cartons

Reason for recall

Sub-potent Drug; powder discoloration associated with decreased potency

Recall record

Recall number: D-0485-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2024-04-08
Classified by FDA Center: 2024-05-06
FDA published: 2024-05-15
Recalling firm: Dr. Reddy's Laboratories, Inc.
Firm location: Princeton, NJ

Drug identification

Brand name(s): JAVYGTOR
Generic name(s): SAPROPTERIN DIHYDROCHLORIDE
Manufacturer(s): Dr. Reddys Laboratories Inc
NDC(s): 43598-097
Route(s): ORAL

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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