thejoe Plastikon Healthcare LLC

Plastikon Healthcare LLC: 25 FDA recall reports

Every drug recall the FDA has published for Plastikon Healthcare LLC. The fault, and how the agency graded it.

25Reports

7Class I

0Ongoing

2022-09-14Most recent

7 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	18
Class I	7

By year reported

Year	Reports
2019	1
2022	24

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton,

D-1488-2022 · Class II · reported 2022-09-14 · Terminated

Why it was recalled: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product: Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 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 0904-6740-70
Where it went: Distributed Nationwide in the USA
How much: 217,700 cups

Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton

D-1489-2022 · Class II · reported 2022-09-14 · Terminated

Why it was recalled: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product: Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 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 0904-6741-72
Where it went: Distributed Nationwide in the USA
How much: 349,100 cups

Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For In

D-1484-2022 · Class II · reported 2022-09-14 · Terminated

Why it was recalled: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product: Acetaminophen Oral Solution 160 mg / 5 mL, 5 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 0904-6738-70
Where it went: Distributed Nationwide in the USA
How much: 290,270 cups

Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 trays per carto

D-1485-2022 · Class II · reported 2022-09-14 · Terminated

Why it was recalled: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product: Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 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 0904-6739-71
Where it went: Distributed Nationwide in the USA
How much: 848,500 cups

MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays pe

D-1481-2022 · Class II · reported 2022-09-14 · Terminated

Why it was recalled: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product: MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 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 0904-6840-72.
Where it went: Distributed Nationwide in the USA
How much: 92,200 cups

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

D-1483-2022 · Class II · reported 2022-09-14 · Terminated

Why it was recalled: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product: Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 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 0904-6839-73
Where it went: Distributed Nationwide in the USA
How much: 88,500 cups

CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL

D-1493-2022 · Class II · reported 2022-09-14 · Terminated

Why it was recalled: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product: CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-311-05 UPC 8 60003 67145 0
Where it went: Distributed Nationwide in the USA
How much: 1,464 ampoules

Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton,

D-1486-2022 · Class II · reported 2022-09-14 · Terminated

Why it was recalled: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product: Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 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 0904-6820-76
Where it went: Distributed Nationwide in the USA
How much: 3,507,740 cups

Class I

MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays pe

D-1477-2022 · Class I · reported 2022-09-14 · Terminated

Why it was recalled: Microbial Contamination of Non-Sterile Products.
Product: MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 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 0904-6840-72.
Where it went: Distributed Nationwide in the USA
How much: 7,700 cups

Class I

Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in

D-1478-2022 · Class I · reported 2022-09-14 · Terminated

Why it was recalled: Microbial Contamination of Non-Sterile Products.
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
Where it went: Distributed Nationwide in the USA
How much: 220,500 cups

CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 4 trays per carton, F

D-1487-2022 · Class II · reported 2022-09-14 · Terminated

Why it was recalled: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product: CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 4 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-7098-94
Where it went: Distributed Nationwide in the USA
How much: 49,280 cups

Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in

D-1482-2022 · Class II · reported 2022-09-14 · Terminated

Why it was recalled: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
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
Where it went: Distributed Nationwide in the USA
How much: 521,700 cups

Class I

MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays pe

D-1476-2022 · Class I · reported 2022-09-14 · Terminated

Why it was recalled: Microbial Contamination of Non-Sterile Products
Product: MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 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 0904-6846-73.
Where it went: Distributed Nationwide in the USA
How much: 24,400 cups

CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in

D-1492-2022 · Class II · reported 2022-09-14 · Terminated

Why it was recalled: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product: CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-302-05 UPC 8 60003 67144 3
Where it went: Distributed Nationwide in the USA
How much: 7,200 ampoules

MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays pe

D-1480-2022 · Class II · reported 2022-09-14 · Terminated

Why it was recalled: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product: MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 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 0904-6846-73.
Where it went: Distributed Nationwide in the USA
How much: 502,600 cups

CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorphan 5 mg per 5 mL) 2.04F

D-1494-2022 · Class II · reported 2022-09-14 · Terminated

Why it was recalled: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product: CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorphan 5 mg per 5 mL) 2.04FL. OZ (60mL), packaged in 12-5 individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-321-05 UPC 8 60003 67146 7
Where it went: Distributed Nationwide in the USA
How much: 1,464 ampoules

GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carto

D-1490-2022 · Class II · reported 2022-09-14 · Terminated

Why it was recalled: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product: GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 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 0904-6844-70
Where it went: Distributed Nationwide in the USA
How much: 280,500 cups

Class I

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

D-1479-2022 · Class I · reported 2022-09-14 · Terminated

Why it was recalled: Microbial Contamination of Non-Sterile Products.
Product: Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 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 0904-6839-73
Where it went: Distributed Nationwide in the USA
How much: 43,200 cups

GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton

D-1491-2022 · Class II · reported 2022-09-14 · Terminated

Why it was recalled: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product: GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 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 0904-6980-72
Where it went: Distributed Nationwide in the USA
How much: 246,200 cups

Class I

Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per t

D-0868-2022 · Class I · reported 2022-05-25 · Completed

Why it was recalled: Microbial Contamination of Non-Sterile Products
Product: Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distribute by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.
Where it went: Distributed in Indiana for further distribution in the USA.
How much: 23,300 Unit Dose cups

Class I

MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays

D-0867-2022 · Class I · reported 2022-05-25 · Completed

Why it was recalled: Microbial Contamination of Non-Sterile Products
Product: 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 went: Distributed in Indiana for further distribution in the USA.
How much: 14,100 Unit Dose cups

Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For In

D-0869-2022 · Class II · reported 2022-05-25 · Completed

Why it was recalled: CGMP Deviations: Failure to properly investigate failed microbial testing.
Product: Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.
Where it went: Distributed in Indiana for further distribution in the USA.
How much: 121,800 Unit Dose cups

Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per t

D-0871-2022 · Class II · reported 2022-05-25 · Completed

Why it was recalled: CGMP Deviations: Failure to properly investigate failed microbial testing.
Product: Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 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: 0904-6838-73.
Where it went: Distributed in Indiana for further distribution in the USA.
How much: 106,400 Unit Dose cups

MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays

D-0870-2022 · Class II · reported 2022-05-25 · Completed

Why it was recalled: CGMP Deviations: Failure to properly investigate failed microbial testing.
Product: 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 went: Distributed in Indiana for further distribution in the USA.
How much: 5,400 Unit Dose cups

Class I

Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, For Institutional Use

D-1879-2019 · Class I · reported 2019-09-18 · Terminated

Why it was recalled: Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.
Product: Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, For Institutional Use Only, packaged in 100-count cartons of 10 trays x 10 unit dose cups, Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.
Where it went: One distributor who further distributed Nationwide in the USA.
How much: 1,433 cases

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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