Perrigo Children's Pain & Fever Bubblegum Flavored Recall

Why it was recalled

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

Product description

Children's Pain & Fever Bubblegum Flavored Acetaminophen Suspension (160mg/5ml), 4 fl oz (118 mL) per bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716. NDC: 49035-313-26

Lot numbers, UPCs & expiration codes

Batch: 1BK0784, Exp 12/31/2022; 1CK0997, 1CK1083, Exp 01/31/2023

Where it was sold

Nationwide in the USA

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0580-2022
Classification: Class II
Status: Terminated
Recall initiated: Oct 26, 2021
FDA report date: Mar 2, 2022
Quantity: 117552 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Perrigo Company PLC

Original FDA data

Every field from FDA enforcement report D-0580-2022, exactly as published.

Show all FDA fields

City: Allegan
State: MI
Status: Terminated
Country: United States
Event ID: 88905
Address: 515 Eastern Ave
Code information: Batch: 1BK0784, Exp 12/31/2022; 1CK0997, 1CK1083, Exp 01/31/2023
Postal code: 49010-9070
Report date: Mar 2, 2022
Product type: Drugs
Recall number: D-0580-2022
Classification: Class II
Recalling firm: Perrigo Company PLC
Product quantity: 117552 bottles
Termination date: Sep 29, 2023
Reason for recall: CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Children's Pain & Fever Bubblegum Flavored Acetaminophen Suspension (160mg/5ml), 4 fl oz (118 mL) per bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716. NDC: 49035-313-26
Distribution pattern: Nationwide in the USA
Recall initiation date: Oct 26, 2021
Initial firm notification: Letter
Center classification date: Feb 23, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0580-2022, published Mar 2, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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