Apotex Recalls Subpotent Leflunomide Tablets Due to Specification Failure
Apotex Corp. is recalling 31 bottles of Leflunomide 20 mg tablets because the product did not meet specifications. The recall is nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which involves a risk of temporary or medically reversible adverse health consequences. Subpotent drugs are a high-risk hazard because patients may not receive the intended therapeutic effect, potentially leading to disease progression or treatment failure, even if no specific injuries are reported in the source text.
Plain-English summary
Apotex Corp. is recalling 31 bottles of Leflunomide 20 mg tablets, 1000-count, prescription only. The product was manufactured for Apotex Corp. in Weston, Florida, by Apotex Inc. in Toronto, Ontario, Canada. The specific lot number is GZ1274, with an expiration date of 11/07.
The recall was initiated because the product was subpotent, meaning it did not meet the required specifications for a single-ingredient drug. This classification indicates that the medication may not contain the full amount of the active ingredient it is supposed to have.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or supplier for disposal or credit, as directed by the recalling firm.
The recalled product
- Product
- LEFLUNOMIDE (LEFLUNOMIDE)
- Brand
- LEFLUNOMIDE
- Manufacturer
- Apotex Corp.
- Category
- Drug — Prescription Medication
- Affected units
- 31
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: GZ1274
- Exp 11/07.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Apotex Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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