CLASS II Drug recall · Reported 5 Sep 2012 · FDA Enforcement Report
Leflunomide tablets, 20 mg recalled by Apotex
Apotex is recalling Leflunomide tablets, 20 mg, distributed nationwide in the US. The recall was initiated on 14 Jun 2007 and the FDA has classified it as Class II.
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-1662-2012
- FDA event ID
- 38329
- Recalling firm
- Apotex, Weston, FL
- Brand
- Leflunomide
- Manufacturer
- Apotex Corp.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Jun 2007
- FDA classified
- 27 Aug 2012
- Reported
- 5 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- FAX
- Reason category
- Potency & Assay
Timeline
| 14 Jun 2007 | Recall initiated by company | |
| 27 Aug 2012 | Classified by FDA | +1901 days |
| 5 Sep 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
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
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
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Which lots are affected?
Lot #: GZ1274, Exp 11/07.
Where was it sold?
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
1 other product · FDA event 38329This product is part of a recall event; the main page for the event is Leflunomide tablets, 10 mg, a) bottle recalled by Apotex.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Leflunomide tablets, 10 mg, a) bottle recalled by ApotexLeflunomide | Apotex | Potency & Assay | Nationwide |
More recalls from Apotex
All 76| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Paroxetine Extended-Release Tablets, 37.5mg recalled by ApotexParoxetine Hydrochloride | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Desmopressin Nasal Spray, USP, 10 mcg/ bottle (50 doses) recalled | Apotex | Other | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | Nationwide |
Other Leflunomide recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Leflunomide Tablet, 10 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Leflunomide tablets, 10 mg, a) bottle recalled by ApotexLeflunomide | Apotex | Potency & Assay | Nationwide |