Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Sirolimus Oral Solution Recalled by Apotex Corp. Due to Failed Dissolution Specifications: Sirolimus Oral Solution recalled due...
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 Corp. directly.
Affected Products
Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-6197-2
Quantity: 2353 bottles
Why Was This Recalled?
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Apotex Corp.
Apotex Corp. has 30 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report