Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Nisoldipine Extended Release Tablets Recalled by Shionogi Inc. Due to Failed USP Dissolution Test Requirements: Out of Specification...
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, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured by SkyePharma production SAS 38297, Saint Quentin-Pallavier, France, NDC: 0677-1979-01
Quantity: 7230 bottles
Why Was This Recalled?
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
Where Was This Sold?
This product was distributed to 1 state: PA
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