US Drug Recall Register
Class I · High risk Terminated Initiated Sep 25, 2015 (11 years ago)

ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottle…

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.

What was recalled

ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-642-30.

Recalling firm
Medline Industries Inc
NDC code
53329-642-30
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0663-2016

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Acetaminophen recalls

See all