Varenicline Tablets recall
FDA recall D-0219-2026 · initiated Nov 11, 2025
Dr. Reddy's Laboratories, Inc. recalled Varenicline Tablets in Nov 2025 — an FDA Class III recall (D-0219-2026) because Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4800 54-count bottles
Details
- Product
- Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
- Recalling company
- Dr. Reddy's Laboratories Limited
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Distributed Nationwide
- Initiated
- Nov 11, 2025
- FDA report date
- Dec 17, 2025
Frequently asked
- Was Varenicline Tablets recalled?
- Dr. Reddy's Laboratories, Inc. recalled Varenicline Tablets in Nov 2025 — an FDA Class III recall (D-0219-2026) because Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Varenicline Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0219-2026 was: Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
- Is a recalled Varenicline Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Varenicline Tablets are affected?
- Distributed: Distributed Nationwide. The recall covers these lots — Lot # F2400244, Exp Date: 10/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0219-2026.