HydrOXYzine Hydrochloride Tablets — Class III drug recall D-1239-2015
Terminated recall by Qualitest Pharmaceuticals, reported 2015-07-22, distributed nationwide. Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
| Recall number | D-1239-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qualitest Pharmaceuticals, Huntsville, AL, United States |
| Recall initiated | 2015-06-29 |
| Classified | 2015-07-15 |
| Reported by FDA | 2015-07-22 |
| Terminated | 2016-10-23 |
| Distributed | Nationwide (US) |
| Quantity | 47,376 bottles |
| NDC | 00603-3968-21, 00603-3968-28, 00603-3968-32 |
| Lot numbers | 1000, 3/16, 500, 6/15, T115D14A, T115D14B, T130G13B, T132G13A, T132G13B, T144F13A, T144F13B, T144F13C |
Product
HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL
Reason for recall
Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
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-1239-2015. 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.