Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Nisoldipine Extended Release Tablets Recalled by Shionogi Inc. Due to Failed Dissolution Specifications
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 Shionogi Inc. directly.
Affected Products
Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release tablets, 100-count bottle (NDC 59630-501-10, UPC 3 59630 50110 5), Manufactured for: Shionogi, Inc., Florham Park, NJ 07932; and b) Nisoldipine Extended Release tablets, 100-count bottle (NDC 66993-473-02, UPC 3 6693 47302 4), Manufactured for: Prasco Laboratories, Mason, OH 45040; Rx only; Manufactured by: Aenova France SAS, 38291 Saint Quentin-Falavier, France.
Quantity: a) 483 bottles; b) 5,631 bottles
Why Was This Recalled?
Failed Dissolution Specifications
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Shionogi Inc.
Shionogi Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report