Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in
Summary
The FDA issued a Class III for Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laborato by Dr. Reddy's Laboratories, Inc.. Reason: Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit..
Details
Source
Drug Recall
External ID
D-0219-2026
Action Date
2025-12-17
Status
Ongoing
Category
drug
Product Description
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Lot/Code Info: Lot # F2400244, Exp Date: 10/31/2026
Quantity Affected: 4800 54-count bottles
Reason for Recall
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Distribution
Distributed Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-11
Company
Princeton, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 54 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Dr. Reddy's Laboratories, Inc. has 65 FDA actions in our database, including 65 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Dr. Reddy's Laboratories, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Dr. Reddy's Laboratories, Inc. have FDA actions?
Dr. Reddy's Laboratories, Inc. has 65 FDA actions in our database, including 65 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0219-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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