Zolpidem Tartrate Tablets (American Health) – mispackaging risk (2013)
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
Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, Rx Only, Manufactured for Wockhardt USA LLC., Parsippany, NJ 07054 by Wockhardt Limited, Mumbai, India, NDC 68084-225-01
Brand
American Health Packaging
Lot Codes / Batch Numbers
Lot #: 114215, Exp 7/13, 114216, Exp 7/13, 114217, Exp 7/13, 120087, Exp 9/13, 120295, Exp 9/13, 121573, Exp 6/14, 123572, Exp 9/14, 123983, Exp 9/14, 130071, Exp 2/15
Products Sold
Lot #: 114215, Exp 7/13; 114216, Exp 7/13; 114217, Exp 7/13; 120087, Exp 9/13; 120295, Exp 9/13; 121573, Exp 6/14; 123572, Exp 9/14; 123983, Exp 9/14; 130071, Exp 2/15
American Health Packaging is recalling Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, due to Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of indiv. 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
Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet.
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