Medications & Supplements/Over-the-Counter

Major Pharmaceuticals Milk of Magnesia and Acetaminophen Microbial Recall

Agency Publication Date: May 13, 2022

Summary

Plastikon Healthcare LLC is recalling approximately 271,000 unit dose cups of Milk of Magnesia (magnesium hydroxide), Magnesium/Aluminum Hydroxide/Simethicone, and Acetaminophen oral solutions. These products, sold under the Major Pharmaceuticals brand, are being recalled due to potential microbial contamination and manufacturing failures. No incidents or injuries have been reported to date.

Risk

The non-sterile products may be contaminated with microbes, which can cause serious or life-threatening infections in patients with compromised immune systems or other underlying health conditions.

What You Should Do

This recall affects unit dose cups of Milk of Magnesia (2400 mg), Magnesium/Aluminum Hydroxide/Simethicone (1200mg/1200mg/120mg), and Acetaminophen (650mg) oral solutions distributed by Major Pharmaceuticals.
Identify affected products by checking for NDC codes 0904-6846-73, 0904-6838-73, or 0904-6820-76 and specific lot numbers including 20024A, 21067A, 20040A, 20041A, and others. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: MILK OF MAGNESIA USP (Magnesium Hydroxide) (2400 mg/30 mL)by Major Pharmaceuticals

Variants: 30 mL cup, Unit Dose

Lot Numbers:

20024A (Exp Mar 2022)

20025A (Exp Mar 2022)

20041A (Exp May 2022)

NDC:

0904-6846-73

Product: Magnesium Hydroxide, Aluminum Hydroxide, and Simethicone Oral Suspension (1200mg/1200mg/120mg per 30 mL)by Major Pharmaceuticals

Variants: 30 mL cup, Unit Dose

Lot Numbers:

21067A (Exp Jun 2023)

20042A (Exp May 2022)

20043A (Exp May 2022)

20045A (Exp May 2022)

20046A (Exp May 2022)

20047A (Exp May 2022)

NDC:

0904-6838-73

Product: Acetaminophen Oral Solution, USP (650mg/20.3 mL)by Major Pharmaceuticals

Variants: 20.3 mL cup, Unit Dose

Lot Numbers:

20040A (Exp May 2022)

NDC:

0904-6820-76

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89879

Status: Resolved

Manufacturer: Plastikon Healthcare LLC

Sold By: Major Pharmaceuticals; Hospitals; Healthcare Institutions

Manufactured In: United States

Units Affected: 5 products (14,100 Unit Dose cups; 23,300 Unit Dose cups; 121,800 Unit Dose cups; 5,400 Unit Dose cups; 106,400 Unit Dose cups)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects unit dose cups of Milk of Magnesia (2400 mg), Magnesium/Aluminum Hydroxide/Simethicone (1200mg/1200mg/120mg), and Acetaminophen (650mg) oral solutions distributed by Major Pharmaceuticals.

Identify affected products by checking for NDC codes 0904-6846-73, 0904-6838-73, or 0904-6820-76 and specific lot numbers including 20024A, 21067A, 20040A, 20041A, and others. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: MILK OF MAGNESIA USP (Magnesium Hydroxide) (2400 mg/30 mL)by Major Pharmaceuticals

Variants: 30 mL cup, Unit Dose

Lot Numbers:

20024A (Exp Mar 2022)

20025A (Exp Mar 2022)

20041A (Exp May 2022)

NDC:

0904-6846-73

Product: Magnesium Hydroxide, Aluminum Hydroxide, and Simethicone Oral Suspension (1200mg/1200mg/120mg per 30 mL)by Major Pharmaceuticals

Variants: 30 mL cup, Unit Dose

Lot Numbers:

21067A (Exp Jun 2023)

20042A (Exp May 2022)

20043A (Exp May 2022)

20045A (Exp May 2022)

20046A (Exp May 2022)

20047A (Exp May 2022)

NDC:

0904-6838-73

Product: Acetaminophen Oral Solution, USP (650mg/20.3 mL)by Major Pharmaceuticals

Variants: 20.3 mL cup, Unit Dose

Lot Numbers:

20040A (Exp May 2022)

NDC:

0904-6820-76

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89879

Status: Resolved

Manufacturer: Plastikon Healthcare LLC

Sold By: Major Pharmaceuticals; Hospitals; Healthcare Institutions

Manufactured In: United States

Units Affected: 5 products (14,100 Unit Dose cups; 23,300 Unit Dose cups; 121,800 Unit Dose cups; 5,400 Unit Dose cups; 106,400 Unit Dose cups)

Distributed To: Nationwide