Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BusPIRone Hydrochloride Tablets Recalled by Par Pharmaceutical Inc. Due to Failed Impurity /Degradation Specifications

Date: August 10, 2020
Company: Par Pharmaceutical Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Par Pharmaceutical Inc. directly.

Affected Products

BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01

Quantity: 11,347 bottles

Why Was This Recalled?

Failed Impurity /Degradation Specifications

Where Was This Sold?

Product was distributed to 9 major distributors throughout the United States.

About Par Pharmaceutical Inc.

Par Pharmaceutical Inc. has 8 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report