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American Regent, Inc. Issues Voluntary Nationwide

1 recall on record · Last recall: Jul 27, 2026

Safety Score

97/100

Excellent

Based on recall frequency and severity over the past 3 years, with older recalls weighted less.

Severity Breakdown

Class I — Serious
0
Class II — Moderate
0
Class III — Low Risk
0
Unclassified
1

Categories

MEDICATION

Recall Timeline

FDAJul 27, 2026

American Regent, Inc. Issues Voluntary Nationwide Recall of One Lot of Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL Due to the Presence of Visible Particulate Matter

July 24, 2026 – Shirley, NY, American Regent, Inc. is conducting a nationwide voluntary recall of a single lot of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL single dose vial to the consumer level. The product is being recalled due to the presence of particulate matter identified as glass an

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