← FDA ENFORCEMENT
D-0117-2025Class III

Dr. Reddy's Laboratories, Inc.

Recalling firm
Dr. Reddy's Laboratories, Inc.
Product type
Drug
Status
Ongoing
Report date
2024-12-18
Distribution
U.S. Nationwide
Firm state
NJ
Product quantity
7,233 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed Impurities/Degradation Specifications

Product description

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.

Code / lot info

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.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.