Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Extended Phenytoin Sodium Capsules Recalled by Wockhardt Usa Inc. Due to CGMP Deviations: Firm did not adequately investigate customer...
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
Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count Bottles (NDC: 64679-720-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
Quantity: 53,894 Bottles
Why Was This Recalled?
CGMP Deviations: Firm did not adequately investigate customer complaints.
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