varenicline tartratedrugHigh PriorityActive

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 Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56 recalled by FDA. Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

By RecallRadar Editorial Team

Sourced from FDA. Last reviewed March 4, 2026.

This recall involves safety concerns. Take action promptly.

✨ Plain-English Summary

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source: FDA
Announced by source: November 11, 2025
Last reviewed by RecallRadar: March 4, 2026

What You Should Do

1## Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56 Agency: FDA | Category: drug Reason: Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit. What to do:
2Stop using the product if your lot/model matches.
3Check the FDA notice for specifics.
4Follow remedy instructions.

Open Official Recall Notice Get Alerts for varenicline tartrate Devices

What's Being Recalled

Quoted source excerpt from the official notice.

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

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

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

#	Model
1	Lot # F2400244, Exp Date: 10/31/2026

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

Frequently Asked Questions

Is my varenicline tartrate device affected?

Check the affected models section on this page. The official notice currently lists Lot # F2400244, Exp Date: 10/31/2026.

What is the remedy for this recall?

## Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56 Agency: FDA | Category: drug Reason: Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit. What to do: 1. Stop using the product if your lot/model matches. 2. Check the FDA notice for specifics. 3. Follow remedy instructions.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Keep browsing with these internal hubs: varenicline tartrate recall hub and Food & Drug recall hub.