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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Over-the-Counter

Plastikon Healthcare LLC: Milk of Magnesia Recalled for Microbial Contamination

Agency Publication Date: September 11, 2019
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Summary

Approximately 1,433 cases of Milk of Magnesia USP (magnesium hydroxide) 2400 mg/30 mL unit dose cups are being recalled because they failed microbial testing for aerobic bacteria. The product, manufactured by Plastikon Healthcare LLC and distributed under the Major Pharmaceuticals brand, was found to have a total aerobic microbial count that exceeds safety standards. These products were distributed to hospitals and clinics in 100-count cartons containing 10 trays of 10 unit dose cups.

Risk

The product failed bioburden testing, meaning it contains higher than acceptable levels of bacteria. This poses a risk of infection, particularly for vulnerable patients or those with weakened immune systems who may be using the medication in an institutional setting.

What You Should Do

  1. Check your supply for Milk of Magnesia USP (magnesium hydroxide) 2400 mg/30 mL unit dose cups with NDC 0904-6846-73.
  2. Verify if your product belongs to lot numbers 19027D or 19027E, both with an expiration date of 07/21.
  3. Immediately stop using and quarantine any affected unit dose cups from these specific lots.
  4. Contact your healthcare provider or pharmacist for guidance regarding the use of this medication and to discuss alternative treatments.
  5. Return any unused product to the place of purchase for a refund and contact Plastikon Healthcare LLC at their Lawrence, Kansas facility for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug product refund and healthcare consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups
Model:
NDC 0904-6846-73
Recall #: D-1879-2019
Lot Numbers:
19027D (Exp 07/21)
19027E (Exp 07/21)
Date Ranges: Exp 07/21

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83693
Status: Resolved
Manufacturer: Plastikon Healthcare LLC
Sold By: Major Pharmaceuticals; Institutional distributors
Manufactured In: United States
Units Affected: 1,433 cases
Distributed To: Nationwide
Agency Last Updated: September 24, 2019

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 ยท 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.