The Recall Desk
ModerateFDA (Drugs)·D-0332-2015·Announced 2015-01-14

Par Pharmaceutical Recalls HydrALAZINE Tablets Due to Aluminum Particles

Par Pharmaceutical is recalling one lot of HydrALAZINE Hydrochloride tablets because small aluminum particles were found in the product.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a foreign substance (aluminum particles) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets, USP 25 mg, 100 count bottles. The recall is due to the presence of small aluminum particles in the tablets.

The affected product is distributed nationwide. The specific lot number is 26708501, with an expiration date of 01/17. The total quantity involved is 38,788 bottles.

Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or distributor for a refund or replacement.

The recalled product

Product
HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY10977
Affected units
38,788

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot 26708501
  • Exp. 01/17

Distribution

Distributed nationwide across the United States.