CLASS II Drug recall · Reported 9 Apr 2014 · FDA Enforcement Report

HydrOXYzine HCl Tablets, USP 50 mg Blister recalled

American Health Packaging is recalling HydrOXYzine HCl Tablets, USP 50 mg Blister, distributed nationwide in the US. The recall was initiated on 31 Jan 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 120757, Exp. 02/14; Lot 121104, Exp 03/14; Lot 122055, Exp 05/14; Lot 123038, Exp 07/14; Lot 125115, Exp 11/14

Quantity recalled8,570 blister packs

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-1189-2014
FDA event ID: 67881
Recalling firm: American Health Packaging, Columbus, OH
Classification: Class II
Status: Terminated
Recall initiated: 31 Jan 2014
FDA classified: 3 Apr 2014
Reported: 9 Apr 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Drug class: Anxiety & Sleep Medication

Timeline

31 Jan 2014	Recall initiated by company
3 Apr 2014	Classified by FDA	+62 days
9 Apr 2014	Published in enforcement report	+6 days

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

Reason for recall

Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.

Product as listed by the FDA

HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.

Which lots are affected?

Lot 120757, Exp. 02/14; Lot 121104, Exp 03/14; Lot 122055, Exp 05/14; Lot 123038, Exp 07/14; Lot 125115, Exp 11/14

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 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 67881

This product is part of a recall event; the main page for the event is HydrOXYzine HCl Tablets, USP 25 mg Blister recalled.

Reported	Class	Recall	Company	Reason	Where
9 Apr 2014	CLASS II	HydrOXYzine HCl Tablets, USP 25 mg Blister recalled	American Health Packaging	Manufacturing (CGMP) Deviations	Nationwide

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