CLASS II Drug recall · Reported 14 Jan 2015 · FDA Enforcement Report

HydrALAZINE Hydrochloride Tablets, USP 25 mg recalled

Par Pharmaceutical is recalling HydrALAZINE Hydrochloride Tablets, USP 25 mg, distributed nationwide in the US. The recall was initiated on 24 Nov 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 26708501, Exp. 01/17

Quantity recalled38,788 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-0332-2015
FDA event ID: 69999
Recalling firm: Par Pharmaceutical, Spring Valley, NY
Classification: Class II
Status: Terminated
Recall initiated: 24 Nov 2014
FDA classified: 6 Jan 2015
Reported: 14 Jan 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Drug class: Blood Pressure Medication

Timeline

24 Nov 2014	Recall initiated by company
6 Jan 2015	Classified by FDA	+43 days
14 Jan 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

Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small aluminum particles.

Product as listed by the FDA

HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY10977

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small aluminum particles.

Which lots are affected?

Lot 26708501, Exp. 01/17

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.

More recalls from Par Pharmaceutical

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Other Hydralazine recalls

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Reported	Class	Recall	Company	Reason	Where
12 Feb 2025Drug	CLASS II	HydrALAZINE Hydrochloride recalled by Sky Packaging	SKY Packaging	Potency & Assay	Nationwide
12 Feb 2025Drug	CLASS II	HydrALAZINE Hydrochloride , USP, 50mg recalled by Sky Packaging	SKY Packaging	Potency & Assay	Nationwide
20 Nov 2024Drug	CLASS III	Hydralazine HCl Tablets, USP, 25mg recalled by The Harvard Drug Group	The Harvard Drug Group	Potency & Assay	Nationwide
21 Feb 2024Drug	CLASS II	HydrALAZINE Hydrochloride Tablets, USP 10mg recalled	The Harvard Drug Group	Potency & Assay	Nationwide
14 Feb 2024Drug	CLASS III	HydrALAZINE Hydrochloride Tablets, USP, 10 mg (10 x per unit dose recalled	Amerisource Health Services	Potency & Assay	Nationwide