HydrOXYzine Hydrochloride Oral Solution — Class III drug recall D-603-2013
Terminated recall by Hi-Tech Pharmacal Co., Inc., reported 2013-06-26, distributed nationwide. Subpotent; 24 month stability test station
| Recall number | D-603-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hi-Tech Pharmacal Co., Inc., Amityville, NY, United States |
| Recall initiated | 2013-04-30 |
| Classified | 2013-06-14 |
| Reported by FDA | 2013-06-26 |
| Terminated | 2016-05-13 |
| Distributed | Nationwide (US) |
| Reason classes | potency, specification failure |
| NDC | 50383-0796-16 |
| Lot numbers | 608204, 608917 |
| Expiration dates | 2014-01, 2014-02 |
Product
HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16
Reason for recall
Subpotent; 24 month 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-603-2013. 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.