← FDA ENFORCEMENT
D-0485-2024Class I

Dr. Reddy's Laboratories, Inc.

Recalling firm
Dr. Reddy's Laboratories, Inc.
Product type
Drug
Status
Ongoing
Report date
2024-05-15
Distribution
Nationwide in the USA
Firm state
NJ
Product quantity
17,332 cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Sub-potent Drug; powder discoloration associated with decreased potency

Product description

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.

Code / lot info

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

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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.