FDA Recall D-0117-2025

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

Class III Ongoing 538 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

Product

Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-096-04.

Lot / code: Lot #: T2300653, Exp 01/31/2025; T2303956, T2303750, Exp 06/30/2025; T2304190, T2304987, Exp 08/31/2025; T2302026, Exp 03/31/2025; T2302526, Exp 05/31/2025.

Quantity: 7,233 bottles

Reason for recall

Failed Impurities/Degradation Specifications

Recall record

Recall number: D-0117-2025
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S. Nationwide
Recall initiated: 2024-11-22
Classified by FDA Center: 2024-12-12
FDA published: 2024-12-18
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): 43598-096
Route(s): ORAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

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

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