Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Pantaprazole Sodium Delayed Release Tablets Recalled by Wockhardt Usa Inc. Due to Failed Dissolution Specifications; 12 month acid dissolution test...
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 Wockhardt Usa Inc. directly.
Affected Products
Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd Parsippany, NJ 07054 USA. NDC: 64679-0434-02.
Quantity: 1129 bottles
Why Was This Recalled?
Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Wockhardt Usa Inc.
Wockhardt Usa Inc. has 45 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report