Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CycloSPORINE Capsules Recalled by Apotex Inc. Due to Failed Impurities/Degradations Specifications; out of specification results for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Apotex Inc. directly.
Affected Products
CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp., Weston, FL --- NDC 60505-0134-0
Quantity: 19,584 bottles
Why Was This Recalled?
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Apotex Inc.
Apotex Inc. has 41 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report