Hydroxyzine Hydrochloride Oral Solution (Akorn) – Impurity Specs Failure (2015)
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, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 50383-0796-16
Brand
Akorn, Inc.
Lot Codes / Batch Numbers
Lot# 620984, 620987, Exp 04/2015, 621481, 621484, 621752, 621754 Exp 05/2015, 621875, 622239 Exp 06/2015, 622742, 622745, 623371 Exp 08/2015, 623374, 623820, 623823 Exp 09/2015, 624265, 624268 Exp 10/2015, 624824, 624827 Exp 11/2015, 625472, 625475 Exp 01/2016, 625783, 625786, 626447, 626450 02/2016, 627683, 627797 Exp 05/2016, 627800 Exp 06/2016, 629094, 629097, 629100, 629103 Exp 08/2016, 629928 Exp 09/2016, 629931, 630480, 630483 Exp 10/2016, 630874, 630877, 631513 Exp 12/2016
Products Sold
Lot# 620984, 620987, Exp 04/2015; 621481, 621484, 621752, 621754 Exp 05/2015; 621875, 622239 Exp 06/2015; 622742, 622745, 623371 Exp 08/2015; 623374, 623820, 623823 Exp 09/2015; 624265, 624268 Exp 10/2015; 624824, 624827 Exp 11/2015; 625472, 625475 Exp 01/2016; 625783, 625786, 626447, 626450 02/2016; 627683, 627797 Exp 05/2016; 627800 Exp 06/2016; 629094, 629097, 629100, 629103 Exp 08/2016; 629928 Exp 09/2016; 629931, 630480, 630483 Exp 10/2016; 630874, 630877, 631513 Exp 12/2016
Akorn, Inc. is recalling Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufac due to Failed Impurities/Degradation Specifications. 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 Impurities/Degradation Specifications
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 7, 2026