Recall: D-0219-2026

Class III - Minor Violations

Class IIIClassification

2025-11-11Initiated

OngoingStatus

Dr. Reddy's Laboratories, Inc.Firm

Product

Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56

Reason

Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

Distribution

Distributed Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.