FDAClass IIMarch 2, 2022

Acetaminophen Infant Dye Free Grape Oral Suspension recall: CGMP Deviations

Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentoneville, AR 72716. NDC: 49035-766-16

Why was Acetaminophen Infant Dye Free Grape Oral Suspension recalled?

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

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?

Batch: 1CK1274, Exp 02/28/2023

Product
Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentoneville, AR 72716. NDC: 49035-766-16
Recalling firm
Perrigo Company PLC
Quantity
55,656 bottles
Distribution
Nationwide in the USA
Recall date
March 2, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls