HydrOXYzine HCl Tablets — Class II drug recall D-1188-2014
Terminated recall by American Health Packaging, reported 2014-04-09, distributed nationwide. Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapprove
| Recall number | D-1188-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Health Packaging, Columbus, OH, United States |
| Recall initiated | 2014-01-31 |
| Classified | 2014-04-03 |
| Reported by FDA | 2014-04-09 |
| Terminated | 2015-04-01 |
| Distributed | Nationwide (US) |
| Quantity | 14,665 blister |
| Reason classes | cgmp, unapproved product |
| NDC | 68084-0254-01 |
| Lot numbers | 01/14, 03/14, 05/14, 06/14, 12/14, 120407, 121337, 122054, 122598, 130125 |
Product
HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01
Reason for recall
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1188-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.