Teva Hydroxyzine Pamoate Capsules — Class II drug recall D-1095-2014
Terminated recall by Teva Pharmaceuticals USA, reported 2014-03-12, distributed nationwide. CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API
| Recall number | D-1095-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Horsham, PA, United States |
| Recall initiated | 2014-01-24 |
| Classified | 2014-02-28 |
| Reported by FDA | 2014-03-12 |
| Terminated | 2014-10-08 |
| Distributed | Nationwide (US) |
| Quantity | 35,746 capsules |
| Reason classes | cgmp, unapproved product |
| NDC | 00555-0302, 00555-0302-02, 00555-0302-04, 00555-0323, 00555-0323-02, 00555-0323-04, 00555-0324, 00555-0324-02 |
| Lot numbers | 09/16, 34016752A, 34016753A |
Product
Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0323-02.
Reason for recall
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
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-1095-2014. 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.