Lower riskDrug recall · FDA · Published November 11, 2025
Dr. Reddy's Varenicline Tablets Recall: Subpotent Drug Risk
Dr. Reddy's recalls 1mg Varenicline tablets due to subpotent drug levels found in a specific lot during stability testing. This may affect prescription medication efficacy.
“Dr. Reddy's Varenicline Tablets Recall: Subpotent Drug Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31641-dr-reddy-s-varenicline-tablets-recall-subpotent-drug-risk. Based on FDA recall #D-0219-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0219-2026%22&limit=1).
The FDA announced on 2025-11-11 that Dr. Reddy's Laboratories, Inc. is voluntarily recalling Varenicline Tablets, 1mg, due to sub-potent drug risks. The agency stated the recall addresses assay values falling below specification limits during stability testing.
How to tell if you have it
Brand: Dr. Reddy's
Product: Varenicline Tablets, 1mg, 56 Tablets, Rx only
NDC: 43598-908-56
Lot #: F2400244
Exp Date: 10/31/2026
Quantity: 4800 bottles
Distribution: Nationwide
The hazard
The recall addresses sub-potent drugs where the assay value for the affected lot was below specification limits during a 9-month stability test. The FDA classified this as a Class III recall.
Context
GovInfoNow's records show Dr. Reddy's Laboratories, Inc. has 85 other recalls on record since 2012-04-09. Other recent recalls of similar products include Dr. Reddy's Succinylcholine Chloride Injection Recall (2025-09-26), Dr. Reddy's Omeprazole Capsules Recall (2025-06-30), and Dr. Reddy's Levetiracetam Injection Label Mix-Up Recall (2025-03-13). Other recent recalls of similar products include Unichem busPIRone 5mg Tablets Recall (2026-04-13), Major Pharmaceuticals Levothyroxine Tablets Recall (2026-07-13), and AvKARE Rosuvastatin Tablets 10mg Recall (2025-12-31).
How to tell if you have this one
Check your prescription label for the lot number F2400244 and expiration date 10/31/2026. The product is a 1mg Varenicline tablet, 56 tablets, sold by Dr. Reddy's Laboratories Inc. in Princeton, NJ.
Brand
Dr. Reddy's
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the lot number F2400244 and expiration date 10/31/2026 on the prescription label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Distributed Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 36 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0219-2026 (November 11, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0219-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.