Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Risperidone Oral Solution Recalled by Apotex Inc. Due to Failed Impurities/Degradation Specifications: Out of Specification for an...
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
Risperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-0380-1.
Quantity: 11,422 bottles
Why Was This Recalled?
Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point.
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