Apotex Leflunomide Tablets 10mg Recall: Subpotent Drug Risk
Apotex recalls 10mg leflunomide tablets (30-count and 1000-count bottles) due to subpotent quality. These prescription drugs may not meet strength specifications.
Lower-risk recall
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Contact the company
What happened, in plain English
Apotex is recalling 10mg leflunomide tablets in 30-count and 1000-count bottles because they did not meet the required strength specifications. This could affect the drug's effectiveness for patients using it for autoimmune conditions. Read more at govinfonow.com/recall/48998-apotex-leflunomide-tablets-10mg-recall-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/48998-apotex-leflunomide-tablets-10mg-recall-subpotent-drug-risk · Updated August 19, 2026 · FDA enforcement record: FDA #D-1661-2012
Cite this page
“Apotex Leflunomide Tablets 10mg Recall: Subpotent Drug Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/48998-apotex-leflunomide-tablets-10mg-recall-subpotent-drug-risk. Based on FDA recall #D-1661-2012 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1661-2012%22&limit=1).
Why it’s dangerous
The tablets did not meet the required strength specifications. This means the medication might not work as intended for patients who need it for conditions like rheumatoid arthritis.
Who’s affected
Prescription patients using Apotex leflunomide tablets. Those with autoimmune conditions like rheumatoid arthritis may be most affected.
How to tell if you have this one
Check for Apotex brand tablets labeled 10mg leflunomide. The 30-count bottle has NDC 60505-2502-1 and the 1000-count bottle has NDC 60505-2502-3. These are prescription-only products.
- Brand
Apotex- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide.- NDC
60505-2502-1, 60505-2502-2, 60505-2502-3, 60505-2503-1, 60505-2503-2, 60505-2503-3
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1661-2012 | Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9; Lot #: a) GY4197, Exp 11/07; b) GZ1273, Exp 11/07. | 3063 |
| D-1662-2012 | Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9, NDC 60505-2503-3; Lot #: GZ1274, Exp 11/07. | 31 |
What to do — step by step
Check Product Details
Look for the NDC codes 60505-2502-1 (30-count) or 60505-2502-3 (1000-count) on the bottle.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 5.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- FDA terminated the recall
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-1661-2012 (June 14, 2007) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1661-2012 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.