HydrALAZINE Tablets (Par) – Foreign Substance (2014)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY10977
Brand
Par Pharmaceutical Inc.
Lot Codes / Batch Numbers
Lot 26708501, Exp. 01/17
Products Sold
Lot 26708501, Exp. 01/17
Par Pharmaceutical Inc. is recalling HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmace due to Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small alumin. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small aluminum particles.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 13, 2026