FDA Drug recall D-1239-2015
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-…
- FDA Drug
- Class III
- terminated
- Published 2015-07-22
On 2015-07-22 the FDA classified a Class III recall of 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-… by Qualitest Pharmaceuticals, citing failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1239-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-06-29 |
| Published | 2015-07-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Qualitest Pharmaceuticals |
| Distribution | US |
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
Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
Identifiers
| code_info | 100 count (NDC 0603-3968-21); LOTS# T144F13A, T130G13B, T132G13A, exp date 6/15, T115D14A, exp date 3/16; 500 count (…100 count (NDC 0603-3968-21); LOTS# T144F13A, T130G13B, T132G13A, exp date 6/15, T115D14A, exp date 3/16; 500 count (NDC 0603-3968-28), LOT# T144F13B exp date 6/15; and 1000 count (NDC 0603-3968-32); LOTS # T144F13C, T132G13B, exp date 6/15, T115D14B, exp date 3/16 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1239-2015%22
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