Par Pharmaceutical HydrALAZINE Hydrochloride Tablets Recall

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

Lot 26708501, Exp. 01/17

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0332-2015
Classification: Class II
Status: Terminated
Recall initiated: Nov 24, 2014
FDA report date: Jan 14, 2015
Quantity: 38,788 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Par Pharmaceutical Inc.

Original FDA data

Every field from FDA enforcement report D-0332-2015, exactly as published.

Show all FDA fields

City: Spring Valley
State: NY
Status: Terminated
Country: United States
Event ID: 69999
Address: 1 RAM Ridge Rd
Code information: Lot 26708501, Exp. 01/17
Postal code: 10977-6714
Report date: Jan 14, 2015
Product type: Drugs
Recall number: D-0332-2015
Classification: Class II
Recalling firm: Par Pharmaceutical Inc.
Product quantity: 38,788 bottles
Termination date: May 1, 2017
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.
Voluntary / mandated: Voluntary: Firm initiated
Product description: HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY10977
Distribution pattern: Nationwide
Recall initiation date: Nov 24, 2014
Initial firm notification: Letter
Center classification date: Jan 6, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0332-2015, published Jan 14, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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