CLASS II Drug recall · Reported 2 Mar 2022 · FDA Enforcement Report

Acetaminophen Child Strawberry Oral Suspension (160 mg recalled

Perrigo is recalling Acetaminophen Child Strawberry Oral Suspension (160 mg/ per, distributed nationwide in the US. The recall was initiated on 26 Oct 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch: 1FK1252, 1GK0905, Exp 01/31/2023

Quantity recalled14,688 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0594-2022
FDA event ID: 88905
Recalling firm: Perrigo, Allegan, MI
Classification: Class II
Status: Terminated
Recall initiated: 26 Oct 2021
FDA classified: 23 Feb 2022
Reported: 2 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Drug class: Pain Medication

Timeline

26 Oct 2021	Recall initiated by company
23 Feb 2022	Classified by FDA	+120 days
2 Mar 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Target Corporation, Minneapolis, MN 55403. NDC: 11673-759-26

Where it was distributed

Nationwide in the USA

Nationwide

Stores named: Target

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Batch: 1FK1252, 1GK0905, Exp 01/31/2023

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

50 other products · FDA event 88905

This product is part of a recall event; the main page for the event is No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant recalled.

Reported	Class	Recall	Company	Reason	Where
2 Mar 2022	CLASS II	No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant recalledEqualine Nasal	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg recalledUp And Up Childrens Acetaminophen	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Severe Congestion Nasal Spray, No Drip Plus Menthol recalledCareone Severe Congestion Nasal	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Maximum Strength No Drip Nasal Spray recalled by Perrigo CompanyNasal	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Children's Pain & Fever Bubblegum Flavored Acetaminophen recalledEquate Childrens Pain And Fever	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Severe Congestion Nasal Spray, No Drip Plus Menthol recalledSignature Care Nasal Decongestant	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Infant's Grape Flavored Acetaminophen Oral Suspension (160mg recalledEquate Pain And Fever	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Acetaminophen Child Dye Free Cherry Flavor Oral Suspension recalledGood Sense Pain And Fever	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Maximum Strength No Drip Nasal Spray recalled by Perrigo CompanyBasic Care No Drip Nasal	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Acetaminophen Child Strawberry Oral Suspension (160 mg recalled	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Severe Congestion No Drip Nasal Spray Plus Menthol recalledDg Health Nasal	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Maximum Strength No Drip Nasal Spray recalled by Perrigo CompanyBasic Care No Drip Nasal	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Acetaminophen Child Strawberry Oral Suspension (160 mg recalled	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Severe Congestion Nasal Spray, No Drip Plus Menthol recalledCareone Severe Congestion Nasal	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Maximum Strength Plus Menthol No Drip Nasal Spray recalledBasic Care No Drip Nasal	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant recalledTopcare Nasal	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg recalledGood Sense Childrens Pain And Fever	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Severe Congestion Nasal Spray, No Drip Plus Menthol recalledTopcare Nasal	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Acetaminophen Child Dye Free Cherry Flavor Oral Suspension recalledChildrens Pain And Fever	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Acetaminophen Infant Dye Free Grape Oral Suspension (160mg recalledUp And Up Acetaminophen	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Maxiumum Strength No Drip Nasal Spray recalled by Perrigo CompanyDg Health Nasal	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Infant's Grape Flavored Acetaminophen Oral Suspension (160mg recalled	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	No Drip Nasal Decongestant, Oxymetazoline HCl recalledSignature Care Nasal Decongestant	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Acetaminophen Child Dye Free Cherry Flavor Oral Suspension recalledEquate Childrens Pain And Fever	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Children's Grape Flavored Acetaminophen Oral Suspension (160mg recalledRugby Childrens Acetaminophen	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Maximum Strength No Drip Nasal Spray recalled by Perrigo CompanyNasal	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Sinus Severe, Oxymetazoline HCl 0.05% Nasal Decongestant recalledDg Health Sinus Severe	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Acetaminophen Infant Dye Free Grape Oral Suspension (160mg recalledInfants Pain And Fever	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Severe Congestion Nasal Spray, No Drip Plus Menthol recalled	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Maximum Strength No Drip Nasal Spray recalled by Perrigo CompanyNasal	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Soothing 12 Hour Nasal Decongestant Spray No Drip recalled	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Children's Grape Flavored Acetaminophen Oral Suspension (160mg recalledDg Health Childrens Pain And Fever	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Children's Grape Flavored Acetaminophen Oral Suspension (160mg recalledEquate Pain And Fever	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Maximum Strength No Drip Nasal Spray recalled by Perrigo CompanyNasal	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Severe Congestion Nasal Spray, No Drip Plus Menthol recalledNasal	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	No Drip Nasal Mist, Oxymetazoline HCl 0.05% Nasal decongestant recalledNasal Mist	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant recalledEquate Nasal	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Acetaminophen Infant Dye Free Grape Oral Suspension (160mg recalledParents Choice Infants Pain And Fever	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Acetaminophen Child Dye Free Cherry Flavor Oral Suspension recalledChildrens Pain And Fever	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Children's Grape Flavored Acetaminophen Oral Suspension (160mg recalledUp And Up Childrens Acetaminophen	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Acetaminophen Child Bubble Gum Flavored Oral Suspension recalledEquate Childrens Pain And Fever	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Severe Congestion Nasal Spray, No Drip Plus Menthol recalled	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Maximum Strength Nasal Spray recalled by Perrigo CompanyNasal	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Acetaminophen Infant Dye Free Grape Oral Suspension (160mg recalledInfants Pain And Fever	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Severe Congestion Nasal Spray, No Drip Plus Menthol recalledEqualine Nasal	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Maximum Strength Nasal Spray recalled by Perrigo CompanyNasal	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Acetaminophen Oral Suspension Grape Flavor, 160 mg recalled	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Nasal Spray Decongestant, No Drip, Oxymetazoline HCl recalledNasal	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Children's Cherry Flavored Acetaminophen Oral Suspension (160mg recalled	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022	CLASS II	Children's Pain & Fever Acetaminophen recalled by Perrigo Company	Perrigo	Manufacturing (CGMP) Deviations	Nationwide

More recalls from Perrigo

All 106

Reported	Class	Recall	Company	Reason	Where
2 Mar 2022Drug	CLASS II	Children's Pain & Fever Acetaminophen recalled by Perrigo Company	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022Drug	CLASS II	Children's Cherry Flavored Acetaminophen Oral Suspension (160mg recalled	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022Drug	CLASS II	Nasal Spray Decongestant, No Drip, Oxymetazoline HCl recalledNasal	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022Drug	CLASS II	Acetaminophen Oral Suspension Grape Flavor, 160 mg recalled	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022Drug	CLASS II	Maximum Strength Nasal Spray recalled by Perrigo CompanyNasal	Perrigo	Manufacturing (CGMP) Deviations	Nationwide

Other Acetaminophen Child Strawberry recalls

All 3

Reported	Class	Recall	Company	Reason	Where
2 Mar 2022Drug	CLASS II	Acetaminophen Child Strawberry Oral Suspension (160 mg recalled	Perrigo	Manufacturing (CGMP) Deviations	Nationwide
2 Mar 2022Drug	CLASS II	Acetaminophen Child Strawberry Oral Suspension (160 mg recalled	Perrigo	Manufacturing (CGMP) Deviations	Nationwide