US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jun 14, 2007 (19 years ago)

Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.

What was recalled

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

Recalling firm
Apotex Corp.
NDC code
60505-2502-1
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1661-2012

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Leflunomide recalls

See all