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

Recall #D-0117-2025 · 11/22/2024

Class III: Low Risk

Recall Details

Recall Number: D-0117-2025
Classification: Class III
Product Type: Drug
Recalling Firm: Dr. Reddy's Laboratories, Inc.
Status: Ongoing
Date Initiated: 11/22/2024
Location: Princeton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7,233 bottles

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.

Distribution Pattern

U.S. Nationwide

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 10/29/2024

Failed Tablet/Capsule 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.