Magnesium Aluminum Simethicone (Plastikon Healthcare) – Microbial Contamination (2022)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6838-73
Brand
Plastikon Healthcare LLC
Lot Codes / Batch Numbers
Lot# 20076A, EXP Jul. 2022, 20079A, 20081A, EXP Aug. 2022, 21096A, EXP Oct. 2022, 21115A, 21103A, EXP Sep. 2022.
Products Sold
Lot# 20076A, EXP Jul. 2022, 20079A, 20081A, EXP Aug. 2022; 21096A, EXP Oct. 2022; 21115A, 21103A, EXP Sep. 2022.
Plastikon Healthcare LLC is recalling Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, pa due to Microbial Contamination of Non-Sterile Products.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Microbial Contamination of Non-Sterile Products.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026