FDA Drug recall D-0048-2015

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 Ph…

FDA Drug
Class II
terminated
Published 2014-11-05

On 2014-11-05 the FDA classified a Class II recall of 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 Ph… by Hi Tech Pharmacal, citing failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0048-2015
Classification	Class II
Status	terminated
Initiated	2014-04-01
Published	2014-11-05
Last updated	2026-09-13 11:51 UTC
Company	Hi Tech Pharmacal
Distribution	US

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

Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.

Identifiers

code_info	Batch 609442 (exp. 4/2014), 609445 (exp. 4/2014), Batch 609919 (exp. 4/2014), Batch 609964 (exp. 5/2014), Batch 609966… Batch 609442 (exp. 4/2014), 609445 (exp. 4/2014), Batch 609919 (exp. 4/2014), Batch 609964 (exp. 5/2014), Batch 609966 (exp. 5/2014), Batch 610204 (exp. 5/2014), Batch 610406 (exp. 5/2014), Batch 610572 (exp. 6/2014), Batch 610575 (exp. 6/2014), Batch 610677 (exp. 6/2014), Batch 610808 (exp. 6/2014), Batch 611110 (exp. 7/2014), Batch 611201 (exp. 8/2014), Batch 611530 (exp. 8/2014), Batch 611645 (exp.9/2014), Batch 611891 (exp. 9/2014), Batch 611993 (exp. 10/2014), Batch 612328 (exp. 11/2014), Batch 612331 (exp. 11/2014), Batch No. 613050 (exp. 12/2014), Batch 613053 (exp. 12/2014), Batch 613172 (exp. 12/2014), Batch 613175 (exp. 12/2014), Batch 613738 (exp. 1/2015), Batch 613741 (exp. 1/2015), Batch 613744 (exp. 1/2015). Batch 613747 (exp. 1/2015), Batch 613852 (exp. 1/2015), Batch 613855 (exp. 2/2015), Batch 614448 (exp. 2/2015), Batch 614451 (exp. 3/2015), Batch 614914 (exp. 3/2015, Batch 614917 (exp. 3/2015), Batch 615331 (exp. 4/2015), Batch 615334 (exp. 4/2015), Batch 615797 (exp

code_info

Batch 609442 (exp. 4/2014), 609445 (exp. 4/2014), Batch 609919 (exp. 4/2014), Batch 609964 (exp. 5/2014), Batch 609966…

Batch 609442 (exp. 4/2014), 609445 (exp. 4/2014), Batch 609919 (exp. 4/2014), Batch 609964 (exp. 5/2014), Batch 609966 (exp. 5/2014), Batch 610204 (exp. 5/2014), Batch 610406 (exp. 5/2014), Batch 610572 (exp. 6/2014), Batch 610575 (exp. 6/2014), Batch 610677 (exp. 6/2014), Batch 610808 (exp. 6/2014), Batch 611110 (exp. 7/2014), Batch 611201 (exp. 8/2014), Batch 611530 (exp. 8/2014), Batch 611645 (exp.9/2014), Batch 611891 (exp. 9/2014), Batch 611993 (exp. 10/2014), Batch 612328 (exp. 11/2014), Batch 612331 (exp. 11/2014), Batch No. 613050 (exp. 12/2014), Batch 613053 (exp. 12/2014), Batch 613172 (exp. 12/2014), Batch 613175 (exp. 12/2014), Batch 613738 (exp. 1/2015), Batch 613741 (exp. 1/2015), Batch 613744 (exp. 1/2015). Batch 613747 (exp. 1/2015), Batch 613852 (exp. 1/2015), Batch 613855 (exp. 2/2015), Batch 614448 (exp. 2/2015), Batch 614451 (exp. 3/2015), Batch 614914 (exp. 3/2015, Batch 614917 (exp. 3/2015), Batch 615331 (exp. 4/2015), Batch 615334 (exp. 4/2015), Batch 615797 (exp

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-0048-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.