Drug FDA Class III Ongoing Sub/super-potent

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

Dr. Reddy's Laboratories, Inc. Published Dec 17, 2025

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Dr. Reddy's Laboratories, Inc. or your place of purchase with questions, and see the source record below for full details.

Reason for recall

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

Hazards

Subpotency · primary

Affected products (1)

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

VARENICLINE TARTRATE · 4800 54-count bottles

NDC: 43598-022, 43598-907, 43598-908, 43598-023, 43598-907-56, 43598-908-56, 43598-023-53, 43598-022-56

Lot codes: F2400244

Code info: Lot # F2400244, Exp Date: 10/31/2026

Affected areas

Nationwide

Timeline

Initiated

Nov 11, 2025
Published

Dec 17, 2025

Recall number: D-0219-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.