Dr. Reddy's Laboratories, Inc.: Drug Recall

Recall #D-0485-2024 · 04/08/2024

Class I: Dangerous

Recall Details

Recall Number: D-0485-2024
Classification: Class I
Product Type: Drug
Recalling Firm: Dr. Reddy's Laboratories, Inc.
Status: Ongoing
Date Initiated: 04/08/2024
Location: Princeton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 17,332 cartons

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.

Distribution Pattern

Nationwide in the USA

Other Recalls by Dr. Reddy's Laboratories, Inc.

Class III: Low Risk 11/11/2025

Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Class II: Risk 09/26/2025

Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Class II: Risk 06/30/2025

Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Class I: Dangerous 03/13/2025

LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
Class III: Low Risk 11/22/2024

Failed Impurities/Degradation Specifications

View all recalls by Dr. Reddy's Laboratories, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.