Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Rabeprazole Sodium Delayed Release Tablets Recalled by Amneal Pharmaceuticals LLC 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 Amneal Pharmaceuticals LLC directly.
Affected Products
Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807
Quantity: 105,215 Bottles
Why Was This Recalled?
Failed Dissolution Specifications
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Amneal Pharmaceuticals LLC
Amneal Pharmaceuticals LLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report