CLASS III ONGOING Drug recall · Reported 17 Dec 2025 · FDA Enforcement Report
Varenicline Tablets, 1mg recalled by Dr. Reddy's Laboratories
Dr. Reddy's Laboratories is recalling Varenicline Tablets, 1mg, distributed nationwide in the US. The recall was initiated on 11 Nov 2025 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0219-2026
- FDA event ID
- 97957
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Brand
- Varenicline Tartrate
- Manufacturer
- Dr. Reddys Laboratories Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 11 Nov 2025
- FDA classified
- 5 Dec 2025
- Reported
- 17 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 11 Nov 2025 | Recall initiated by company | |
| 5 Dec 2025 | Classified by FDA | +24 days |
| 17 Dec 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Where it was distributed
Distributed Nationwide
Questions about this recall
Why was it recalled?
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Which lots are affected?
Lot # F2400244, Exp Date: 10/31/2026
Where was it sold?
Distributed Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Dr. Reddy's Laboratories
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | IBU (ibuprofen) recalled by Dr. Reddy's LaboratoriesIBU | Dr. Reddy's Laboratories | Other | Nationwide |
Other Varenicline recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Chantix (varenicline) tablets 1 mg recalled by PfizerChantix | Pfizer | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Chantix (varenicline) tablets 0.5mg recalled by PfizerChantix | Pfizer | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Chantix (varenicline)Tablets, Contains: 1 Starting Week recalledChantix | Pfizer | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Chantix (varenicline) tablets, 1 mg recalled by PfizerChantix | Pfizer | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Chantix (varenicline) tablets, 0.5mg* recalled by PfizerChantix | Pfizer | Nitrosamine Impurity | Nationwide |