On June 8, 2022, the U.S. Food and Drug Administration (FDA) reported Plastikon Healthcare's voluntarily recall of one lot of Milk of Magnesia 2,400 mg/10 ml oral suspension, one lot of Milk of Magnesia 2,400 mg/30 ml oral suspension, 11 lots of magnesium hydroxide 1,200 mg/aluminum hydroxide 1,200 mg/simethicone 120 mg per 30 ml oral suspension, and two lots of magnesium hydroxide 2,400 mg/aluminum hydroxide 2,400 mg/simethicone 240 mg per 30 ml oral suspension to the consumer level because of microbial contamination.

FDA Reports Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide/Aluminum Hydroxide/Simethicone Oral Suspension

In the recall, Plastikon Healthcare advised that use of oral drug products with microbial contamination could result in infection, which may be life threatening for patients with compromised immune systems. To date, Plastikon Healthcare has not reported any adverse events or injuries related to the recall. 

The following products are included in the recall.  

Product Name 

Milk of Magnesia 2400 mg / 30 mL Oral Suspension 

Milk of Magnesia 2400 mg / 10 mL Oral Suspension 

Magnesium Hydroxide 1200 mg / Aluminum Hydroxide 1200 mg / Simethicone 120 mg per 30 mL Oral Suspension 

Magnesium Hydroxide 2400 mg / Aluminum Hydroxide 2400 mg / Simethicone 240 mg per 30 mL Oral Suspension 

Indications for Use 

Occasional relief of constipation (irregularity) in adults and children 12 years and older or for children under 12 as recommended by a doctor. 

Occasional relief of constipation (irregularity) in adults and children 12 years and older or for children under 12 as recommended by a doctor. 

Relief of acid indigestion, heartburn, sour stomach, upset stomach due to these symptoms, pressure and bloating commonly referred to as gas. 

Relief of acid indigestion, heartburn, sour stomach, upset stomach due to these symptoms, pressure and bloating commonly referred to as gas. 

Lot/Exp. 

20071A / Jul. 2022 

20074A / Jul. 2022 

21103A / Sep. 2023 
20046A / May. 2022 
20079A / Aug. 2022 
20080A / Aug. 2022 
20081A / Aug. 2022 
21057A / May. 2023 
21059A / May. 2023 
21095A / Sep. 2023 
21096A / Sep. 2023 
21099A / Sep. 2023 
21115A / Oct. 2022 

20051A / Aug. 2022 
20088A / Sep. 2022 

NDC 

0904-6846-73 

0904-6840-72 

0904-6838-73 

0904-6839-73 

Packaging 

Carton containing 100 single dose cups (10 trays x 10 cups) 

Carton containing 100 single dose cups (10 trays x 10 cups) 

Carton containing 100 single dose cups (10 trays x 10 cups) 

Carton containing 100 single dose cups (10 trays x 10 cups) 

The affected lots were shipped from Major Pharmaceuticals Distribution Center from July 1, 2020–October 31, 2021, to hospitals, nursing homes, and clinics nationwide and were private labeled for Major Pharmaceuticals. The products were packaged for institutional use in single-use cups with a foil lid. 

FDA reported that Plastikon Healthcare is notifying its direct customers to arrange the return of recalled product. Anyone with recalled inventory should stop using them, quarantine immediately, and return  the product to the place of purchase. Healthcare providers should notify patients who received the product about the recall.  

Patients and consumers with questions regarding the recall can contact Plastikon Healthcare at 785-330-7109 or sdixon@plastikon.com Monday–Friday, from 9 am—4 pm CST. Patients should contact their physician or healthcare provider if they experience any problems that may be related to taking this product.  

Healthcare professionals and consumers should report any adverse reactions or quality problems they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program