Recall archive / FDA company announcement

Major: Milk of Magnesia, Magnisium Hydroxide/Aluminum Hydroxide/Simethicone Oral Suspension — FDA announcement Jun 8, 2022

Reported terminated

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Jun 8, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Milk of Magnesia, Magnisium Hydroxide/Aluminum Hydroxide/Simethicone Oral Suspension
Reason: Due to microbial contamination
Classification: Not supplied
Recalling firm: Plastikon Healthcare, LLC
Quantity: Not supplied
Agency-reported status: Terminated in FDA listing
Source record identifier: c2e59b1c70392312

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	FOR IMMEDIATE RELEASE – 6/07/2022 – Lawrence, Kansas – Plastikon Healthcare, LLC is voluntarily recalling one (1) lot of Milk of Magnesia 2400 mg/10 mL Oral Suspension, one (1) lot of Milk of Magnesia 2400 mg/30 mL Oral Suspension, eleven (11) lots of Magnesium Hydroxide 1200 mg/Aluminum Hydroxide 1200 mg/Simethicone 120 mg per 30 mL Oral Suspension, and two (2) lots of Magnesium Hydroxide 2400 mg/Aluminum Hydroxide 2400 mg/Simethicone 240 mg per 30 mL Oral Suspension to the consumer level. The products are being recalled due to microbial contamination.; Product indication, lot numbers, expiration dates, and NDC information are listed in the table below. The products are packaged for institutional use and are sold to clinics and hospitals nationwide in single use cups with a foil lid. The affected lots were distributed to Major Pharmaceuticals Distribution Center (wholesaler) between 7/1/2020 and 10/31/2021, who shipped to hospitals, nursing homes, and clinics nationwide. The products are private labeled for Major Pharmaceuticals.; 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); Product Identification \| See image below \| See image below \| See image below \| See image below

Label field

Details supplied by the agency

Lot, code or applicability

FOR IMMEDIATE RELEASE – 6/07/2022 – Lawrence, Kansas – Plastikon Healthcare, LLC is voluntarily recalling one (1) lot of Milk of Magnesia 2400 mg/10 mL Oral Suspension, one (1) lot of Milk of Magnesia 2400 mg/30 mL Oral Suspension, eleven (11) lots of Magnesium Hydroxide 1200 mg/Aluminum Hydroxide 1200 mg/Simethicone 120 mg per 30 mL Oral Suspension, and two (2) lots of Magnesium Hydroxide 2400 mg/Aluminum Hydroxide 2400 mg/Simethicone 240 mg per 30 mL Oral Suspension to the consumer level. The products are being recalled due to microbial contamination.; Product indication, lot numbers, expiration dates, and NDC information are listed in the table below. The products are packaged for institutional use and are sold to clinics and hospitals nationwide in single use cups with a foil lid. The affected lots were distributed to Major Pharmaceuticals Distribution Center (wholesaler) between 7/1/2020 and 10/31/2021, who shipped to hospitals, nursing homes, and clinics nationwide. The products are private labeled for Major Pharmaceuticals.; 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); Product Identification | See image below | See image below | See image below | See image below

Match all identifying details in the current notice. A brand name alone is not enough.

Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

FDA company announcement, table 1
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)
Product Identification	See image below	See image below	See image below	See image below

Announcement retrieved Oct 1, 2026. Official announcement.

Distribution

Product indication, lot numbers, expiration dates, and NDC information are listed in the table below. The products are packaged for institutional use and are sold to clinics and hospitals nationwide in single use cups with a foil lid. The affected lots were distributed to Major Pharmaceuticals Distribution Center (wholesaler) between 7/1/2020 and 10/31/2021, who shipped to hospitals, nursing homes, and clinics nationwide. The products are private labeled for Major Pharmaceuticals.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Fda listing date: Jun 8, 2022
Company announcement date: Jun 8, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.