CLASS I Drug recall · Reported 25 May 2022 · FDA Enforcement Report
Milk OF Magnesia USP, (Magnesium Hydroxide), 2400 mg/ cup recalled
Plastikon Healthcare is recalling Milk OF Magnesia USP, (Magnesium Hydroxide), 2400 mg/ cup, distributed in Indiana. The recall was initiated on 24 Mar 2022 and the FDA has classified it as Class I.
Check your package
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-0867-2022
- FDA event ID
- 89879
- Recalling firm
- Plastikon Healthcare, Lawrence, KS
- Classification
- Class I
- 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
- Sterility
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
Microbial Contamination of Non-Sterile Products
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.
Where it was distributed
Distributed in Indiana for further distribution in the USA.
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products
Which lots are affected?
Lot: 20024A, 20025A, EXP Mar 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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 89879This product is part of a recall event; the main page for the event is Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg recalled.
More recalls from Plastikon Healthcare
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Guaifenesin And Dextromethorphan 200-20 mg/ cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg recalled | Plastikon Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Guaifenesin And Dextromethorphan 100 mg-10 mg/ cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Correctdose Children's Cough & Chest Congestion DM recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Milk OF Magnesia USP, 2400 mg/, Magnesium Hydroxide cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
Other Milk Of Magnesia recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Milk OF Magnesia USP, 2400 mg/, Magnesium Hydroxide cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Milk OF Magnesia USP, 2400 mg/, Magnesium Hydroxide cup recalled | Plastikon Healthcare | Sterility | Nationwide |
| Drug | CLASS I | Milk OF Magnesia USP, 2400 mg/, Magnesium Hydroxide cup recalled | Plastikon Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Milk OF Magnesia USP, 2400 mg/, Magnesium Hydroxide cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Milk OF Magnesia USP, (Magnesium Hydroxide), 2400 mg/ cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | IN |