HydrOXYzine Hydrochloride Oral Solution — Class II drug recall D-0048-2015
Terminated recall by Hi-Tech Pharmacal Co., Inc., reported 2014-11-05, distributed nationwide. Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at
| Recall number | D-0048-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hi-Tech Pharmacal Co., Inc., Amityville, NY, United States |
| Recall initiated | 2014-04-01 |
| Classified | 2014-10-27 |
| Reported by FDA | 2014-11-05 |
| Terminated | 2016-09-21 |
| Distributed | Nationwide (US) |
| Quantity | 451,916 bottles |
| Reason classes | specification failure |
| NDC | 10702-0052-16, 50383-0796-16 |
| Lot numbers | 609442, 609919, 609964, 609966, 610204, 610406, 610572, 610575, 610677, 610808, 611110, 611201, 611530, 611645, 611891, 611993, 612328, 612331, 613050, 613053, 613172, 613175, 613738, 613741, 613744, 613747, 613852, 613855, 614448, 614451, 614914, 614917, 615331, 615334, 615797, 615800, 615947, 615950, 616356, 616359 and 20 more |
| Expiration dates | 2014-04, 2014-05, 2014-06, 2014-07, 2014-08, 2014-09, 2014-10, 2014-11, 2014-12, 2015-01, 2015-02, 2015-03, 2015-04, 2015-05, 2015-06, 2015-07, 2015-08, 2015-09, 2015-10, 2015-11, 2015-12, 2016-01, 2016-02 |
Product
HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, ALSO LABELED AS HydrOXYzine HCl Oral Solution, USP, 10 mg / 5 mL, Net Wt 16 fl oz (473 mL), NDC 10702-052-16, Rx Only, Manufactured for: KVK-TECH, INC. NEWTOWN, PA 18940, MADE IN USA, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701.
Reason for recall
Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.
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-0048-2015. 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.