Hydroxyzine Hydrochloride — Class II drug recall D-1129-2015
Terminated recall by Akorn, Inc., reported 2015-06-17, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-1129-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2015-04-07 |
| Classified | 2015-06-09 |
| Reported by FDA | 2015-06-17 |
| Terminated | 2017-11-29 |
| Distributed | Nationwide (US) |
| Quantity | 424,174 bottles |
| Reason classes | specification failure |
| NDC | 10702-0052-16 |
| Lot numbers | 621637, 621640, 622748, 622751, 623599, 623602, 624132, 624135, 628282, 628285, 628288, 628291, 628850, 628853, 628856, 628859, 629797, 629800, 629803, 629806 |
| Expiration dates | 2015-05, 2015-08, 2015-09, 2015-10, 2016-06, 2016-07, 2016-09 |
Product
Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 10702-0052-16
Reason for recall
Failed Impurities/Degradation Specifications
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-1129-2015. 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.