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

Recall #D-0640-2022 · 02/17/2022

Class III: Low Risk

Recall Details

Recall Number: D-0640-2022
Classification: Class III
Product Type: Drug
Recalling Firm: Dr. Reddy's Laboratories, Inc.
Status: Terminated
Date Initiated: 02/17/2022
Location: Princeton, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 340 packets

Reason for Recall

Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.

Product Description

Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC: 43598-477-11 (packet), 43598-477-30 (carton).

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.