HydrOXYzine Tablets (American Health) – Unapproved Ingredient (2014)
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
HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01
Brand
American Health Packaging
Lot Codes / Batch Numbers
Lot 120407, Exp 01/14, Lot 121337 Exp 03/14, Lot 122054, Exp 05/14, Lot 122598, Exp 06/14, Lot 130125, Exp 12/14
Products Sold
Lot 120407, Exp 01/14; Lot 121337 Exp 03/14; Lot 122054, Exp 05/14; Lot 122598, Exp 06/14; Lot 130125, Exp 12/14
American Health Packaging is recalling HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA due to Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.. 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
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
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 10, 2026