CLASS II Drug recall · Reported 5 Nov 2014 · FDA Enforcement Report

HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg recalled

Hi-Tech Pharmacal Co is recalling HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg, distributed nationwide in the US. The recall was initiated on 1 Apr 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch 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).

Quantity recalled451,916 bottles

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-0048-2015
FDA event ID: 67894
Recalling firm: Hi-Tech Pharmacal Co, Amityville, NY
Classification: Class II
Status: Terminated
Recall initiated: 1 Apr 2014
FDA classified: 27 Oct 2014
Reported: 5 Nov 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Anxiety & Sleep Medication

Timeline

1 Apr 2014	Recall initiated by company
27 Oct 2014	Classified by FDA	+209 days
5 Nov 2014	Published in enforcement report	+9 days

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

Reason for recall

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

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, 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.

Where it was distributed

nationwide

Nationwide

Questions about this recall

Is HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg recalled?

Yes. Hi-Tech Pharmacal Co recalled HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg on 1 Apr 2014. The recall is Class II and its status is Terminated. Recall number D-0048-2015.

Why was it recalled?

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

Which lots are affected?

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).

Where was it sold?

nationwide

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

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