Zonisamide 100mg Capsules (American Health) - CGMP investigation (2015)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-11); 5 blister packs per carton (NDC 68084-008-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
Brand
American Health Packaging
Lot Codes / Batch Numbers
Lot#: 132383: Exp Date: 07/31/2015, Lot#: 132989 Exp Date: 10/31/2015
Products Sold
Lot#: 132383: Exp Date: 07/31/2015; Lot#: 132989 Exp Date: 10/31/2015; Lot#: 133694 Exp Date: 03/31/2016l Lot#: 134418A Exp Date: 07/31/2016 & Lot#: 134418B Exp Date: 07/31/2016.
American Health Packaging is recalling Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-11); 5 blister packs per due to CGMP Deviations: Firm did not adequately investigate customer complaints.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026