FDAClass IFebruary 24, 2016

Acetaminophen Regular-strength Pain Reliever Tablets recall: Labeling Error

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

Why was Acetaminophen Regular-strength Pain Reliever Tablets recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

lot # 45810; Exp. 05/18

Product
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
Distribution
Nationwide
Recall date
February 24, 2016
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls