CLASS II Drug recall · Reported 17 Jun 2015 · FDA Enforcement Report

Hydroxyzine Hydrochloride, oral solution, 10 mg recalled by Akorn

Akorn is recalling Hydroxyzine Hydrochloride, oral solution, 10 mg per, distributed nationwide in the US. The recall was initiated on 7 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot# 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

Quantity recalledN/A

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1130-2015
FDA event ID: 71033
Recalling firm: Akorn, Lake Forest, IL
Classification: Class II
Status: Terminated
Recall initiated: 7 Apr 2015
FDA classified: 9 Jun 2015
Reported: 17 Jun 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Anxiety & Sleep Medication

Timeline

7 Apr 2015	Recall initiated by company
9 Jun 2015	Classified by FDA	+63 days
17 Jun 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Impurities/Degradation Specifications

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

Nationwide including Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Failed Impurities/Degradation Specifications

Which lots are affected?

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

Where was it sold?

Nationwide including Puerto Rico

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 71033

Reported	Class	Recall	Company	Reason	Where
17 Jun 2015	CLASS II	Hydroxyzine Hydrochloride, oral solution, 10 mg recalled by Akorn	Akorn	Potency & Assay	Nationwide

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Other Hydroxyzine recalls

All 16

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Drug	CLASS III	hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/ (1 Pint) recalledHydroxyzine Hydrochloride	ANI Pharmaceuticals	Other	Nationwide
30 Dec 2020Drug	CLASS II	Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg recalled	Morton Grove Pharmaceuticals	Potency & Assay	Nationwide
31 Oct 2018Drug	CLASS II	HydrOXYzine Hydrochloride Syrup recalled by Lannett CompanyHydroxyzine Hydrochloride	Lannett	Potency & Assay	Nationwide
5 Oct 2016Drug	CLASS II	Hydroxyzine HCl, 50mg/ml Inj MDV, Rx, Vital Care Compounder recalled	Pharmacy Plus	Sterility	MS
22 Jul 2015Drug	CLASS III	HydrOXYzine Hydrochloride Tablets, USP 25 mg recalled	Qualitest Pharmaceuticals	Other	Nationwide