Hydroxyzine Oral Solution (Hi-Tech) – impurity problem (2014)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Hi-Tech Pharmacal Co., Inc.
Lot Codes / Batch Numbers
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. 5/2015), Batch 615800 (exp. 5/2015), Batch 615947 (exp. 6/2015), Batch 615950 (exp. 6/2015), Batch 616356 (exp. 7/2015), Batch 616359 (exp. 7/2015), Batch 616362 (exp. 7/2015), Batch 616365 (exp. 7/2015), Batch 617066 (exp. 8/2015), Batch 617069 (exp. 8/2015), Batch 617432 (exp. 9/2015), Batch 617435 (exp. 9/2015), Batch 617951 (exp. 10/2015), Batch 617954 (exp. 11/2015), Batch 617957 (exp. 12/2015), Batch 617960 (exp. 12/2015), Batch 618918 (exp. 12/2015), Batch 618920 (exp. 12/2015), Batch 619173 (exp. 1/2016), Batch 619176 (exp. 1/2016), Batch 619543 (exp. 2/2016), Batch 619546 (exp. 2/2016), Batch 620099 (exp. 2/2016), Batch 620102 (exp. 2/2016), Batch 620338 (exp. 2/2016), and Batch 620341 (exp. 2/2016).
Products Sold
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. 5/2015), Batch 615800 (exp. 5/2015), Batch 615947 (exp. 6/2015), Batch 615950 (exp. 6/2015), Batch 616356 (exp. 7/2015), Batch 616359 (exp. 7/2015), Batch 616362 (exp. 7/2015), Batch 616365 (exp. 7/2015), Batch 617066 (exp. 8/2015), Batch 617069 (exp. 8/2015), Batch 617432 (exp. 9/2015), Batch 617435 (exp. 9/2015), Batch 617951 (exp. 10/2015), Batch 617954 (exp. 11/2015), Batch 617957 (exp. 12/2015), Batch 617960 (exp. 12/2015), Batch 618918 (exp. 12/2015), Batch 618920 (exp. 12/2015), Batch 619173 (exp. 1/2016), Batch 619176 (exp. 1/2016), Batch 619543 (exp. 2/2016), Batch 619546 (exp. 2/2016), Batch 620099 (exp. 2/2016), Batch 620102 (exp. 2/2016), Batch 620338 (exp. 2/2016), and Batch 620341 (exp. 2/2016).
Hi-Tech Pharmacal Co., Inc. is recalling HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-1 due to Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability . This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026