CLASS II Drug recall · Reported 25 May 2022 · FDA Enforcement Report

Acetaminophen Oral Solution, USP 650mg/ cup recalled

Plastikon Healthcare is recalling Acetaminophen Oral Solution, USP 650mg/ cup, distributed in Indiana. The recall was initiated on 24 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: 20040A, EXP May 2022

Quantity recalled121,800 Unit Dose cups

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-0869-2022
FDA event ID: 89879
Recalling firm: Plastikon Healthcare, Lawrence, KS
Classification: Class II
Status: Completed
Recall initiated: 24 Mar 2022
FDA classified: 13 May 2022
Reported: 25 May 2022
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Manufacturing (CGMP) Deviations
Drug class: Pain Medication

Timeline

24 Mar 2022	Recall initiated by company
13 May 2022	Classified by FDA	+50 days
25 May 2022	Published in enforcement report	+12 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: Failure to properly investigate failed microbial testing.

Product as listed by the FDA

Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.

Where it was distributed

Distributed in Indiana for further distribution in the USA.

Indiana

Questions about this recall

Why was it recalled?

CGMP Deviations: Failure to properly investigate failed microbial testing.

Which lots are affected?

Lot: 20040A, EXP May 2022

Where was it sold?

Distributed in Indiana for further distribution 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

4 other products · FDA event 89879

This product is part of a recall event; the main page for the event is Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg recalled.

Reported	Class	Recall	Company	Reason	Where
25 May 2022	CLASS I	Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg recalled	Plastikon Healthcare	Sterility	IN
25 May 2022	CLASS I	Milk OF Magnesia USP, (Magnesium Hydroxide), 2400 mg/ cup recalled	Plastikon Healthcare	Sterility	IN
25 May 2022	CLASS II	Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg recalled	Plastikon Healthcare	Manufacturing (CGMP) Deviations	IN
25 May 2022	CLASS II	Milk OF Magnesia USP, (Magnesium Hydroxide), 2400 mg/ cup recalled	Plastikon Healthcare	Manufacturing (CGMP) Deviations	IN

More recalls from Plastikon Healthcare

All 25

Reported	Class	Recall	Company	Reason	Where
14 Sep 2022Drug	CLASS II	Guaifenesin And Dextromethorphan 200-20 mg/ cup recalled	Plastikon Healthcare	Manufacturing (CGMP) Deviations	Nationwide
14 Sep 2022Drug	CLASS I	Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg recalled	Plastikon Healthcare	Sterility	Nationwide
14 Sep 2022Drug	CLASS II	Guaifenesin And Dextromethorphan 100 mg-10 mg/ cup recalled	Plastikon Healthcare	Manufacturing (CGMP) Deviations	Nationwide
14 Sep 2022Drug	CLASS II	Correctdose Children's Cough & Chest Congestion DM recalled	Plastikon Healthcare	Manufacturing (CGMP) Deviations	Nationwide
14 Sep 2022Drug	CLASS II	Milk OF Magnesia USP, 2400 mg/, Magnesium Hydroxide cup recalled	Plastikon Healthcare	Manufacturing (CGMP) Deviations	Nationwide

Other Acetaminophen recalls

All 61

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3 Sep 2025Drug	CLASS II	Acetaminophen Injection 1000 mg/ (10 mg/mL) recalledAcetaminophen	Baxter Healthcare	Packaging Defects	Nationwide
25 Jun 2025Drug	CLASS II	Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Acetaminophen and Ibuprofen (Nsaid) Tablets, 250 mg/125 mg a) recalledAcetaminophen, Ibuprofen	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
18 Dec 2024Drug	CLASS II	Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets recalledSevere Cold And Flu Plus Congestion	LNK International	Manufacturing (CGMP) Deviations	Nationwide