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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Over-the-Counter

Major Pharmaceuticals and Correct Dose Liquid Medications Recalled for Contamination

Agency Publication Date: September 6, 2022
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Summary

Plastikon Healthcare LLC is recalling approximately 7,300,218 unit-dose cups and ampoules of several liquid medications including Milk of Magnesia (magnesium hydroxide), antacids, acetaminophen, and children’s cough and allergy syrups. These products, sold under the Major Pharmaceuticals and Correct Dose brands, may be contaminated with microbes or were manufactured under conditions that did not meet strict quality control standards. No injuries or illnesses have been reported to date. These medications were distributed nationwide to hospitals, clinics, and pharmacies.

Risk

Microbial contamination in non-sterile liquid medications can lead to serious, life-threatening infections. Patients with weakened immune systems or those who are already ill are at the highest risk of severe complications from contaminated products.

What You Should Do

  1. This recall affects various liquid medications sold under the Major Pharmaceuticals and Correct Dose brands, including Milk of Magnesia, antacids, acetaminophen, diphenhydramine (allergy relief), and cough syrups.
  2. Identify if your medication is affected by checking the product name, National Drug Code (NDC), and lot number on the packaging. Because this recall affects hundreds of distinct production lots across 15 different types of medication, see the Affected Products section below for the full list of affected codes and expiration dates.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Plastikon Healthcare LLC directly for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions.

Your Remedy Options

You have 2 options:

💰Option 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a full refund.
🗑️Option 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Major Pharmaceuticals Milk of Magnesia USP (2400 mg/30 mL)
Variants: Magnesium Hydroxide, 30 mL cup
Lot Numbers:
20071A (Exp 07/2022)
20072A (Exp 07/2022)
20075A (Exp 07/2022)
20087A (Exp 08/2022)
20089A (Exp 09/2022)
20090A (Exp 09/2022)
20100A (Exp 10/2022)
20102A (Exp 10/2022)
20106A (Exp 11/2022)
20107A (Exp 11/2022)
20109A (Exp 12/2022)
21010A (Exp 01/2023)
21028A (Exp 03/2023)
21030A (Exp 03/2023)
21032A (Exp 03/2023)
21045A (Exp 04/2023)
21046A (Exp 04/2023)
21054A (Exp 05/2023)
21078A (Exp 07/2023)
21079A (Exp 07/2023)
21085A (Exp 07/2023)
21088A (Exp 08/2023)
NDC:
0904-6846-73

Packaged in 10 cups per tray, 10 trays per carton. For Institutional Use Only.

Product: Major Pharmaceuticals Milk of Magnesia USP (2400 mg/10 mL)
Variants: Magnesium Hydroxide, 30 mL cup
Lot Numbers:
20074A (Exp 07/2022)
20085A (Exp 08/2022)
20099A (Exp 10/2022)
21039A (Exp 05/2023)
21052A (Exp 05/2023)
21114A (Exp 10/2023)
21130A (Exp 12/2023)
21132A (Exp 12/2023)
NDC:
0904-6840-72

Packaged in 10 cups per tray, 10 trays per carton. For Institutional Use Only.

Product: Major Pharmaceuticals Antacid/Antigas Oral Suspension (1200 mg/1200 mg/120 mg per 30 mL)
Variants: Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg, 30 mL cup
Lot Numbers:
20076A (Exp 07/2022)
20079A (Exp 08/2022)
20081A (Exp 08/2022)
21096A (Exp 10/2022)
21115A (Exp 09/2022)
21103A (Exp 09/2022)
20077A (Exp 08/2022)
20080A (Exp 08/2022)
20082A (Exp 08/2022)
21016A (Exp 02/2023)
21026A (Exp 03/2023)
21042A (Exp 04/2023)
21047A (Exp 04/2023)
21050A (Exp 04/2023)
21057A (Exp 05/2023)
21059A (Exp 05/2023)
21060A (Exp 05/2023)
21061A (Exp 06/2023)
21067A (Exp 06/2023)
21070A (Exp 06/2023)
21072A (Exp 06/2023)
21095A (Exp 09/2023)
21097A (Exp 09/2023)
21099A (Exp 09/2023)
21107A (Exp 10/2023)
21109A (Exp 10/2023)
21111A (Exp 10/2023)
21113A (Exp 10/2023)
21138A (Exp 12/2023)
22002A (Exp 01/2024)
22004A (Exp 01/2024)
22005A (Exp 01/2024)
NDC:
0904-6838-73

Packaged in 10 cups per tray, 10 trays per carton. For Institutional Use Only.

Product: Major Pharmaceuticals Antacid/Antigas MAX Oral Suspension (2400 mg/2400 mg/240 mg per 30 mL)
Variants: Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg, 30 mL cup
Lot Numbers:
20051A (Exp 08/2022)
20088A (Exp 09/2022)
20084A (Exp 08/2022)
20086A (Exp 08/2022)
21074A (Exp 07/2023)
21077A (Exp 07/2023)
NDC:
0904-6839-73

Packaged in 10 cups per tray, 10 trays per carton. For Institutional Use Only.

Product: Major Pharmaceuticals Acetaminophen Oral Solution (160 mg / 5 mL)
Variants: 5 mL cup
Lot Numbers:
20078A (Exp 08/2022)
20083A (Exp 08/2022)
20092A (Exp 09/2022)
21058A (Exp 05/2023)
21048C (Exp 05/2023)
21063C (Exp 06/2023)
21093B (Exp 09/2023)
22001C (Exp 01/2024)
22017A (Exp 03/2024)
NDC:
0904-6738-70

Packaged in 10 cups per tray, 10 trays per carton. For Institutional Use Only.

Product: Major Pharmaceuticals Acetaminophen Oral Solution (325 mg / 10.15 mL)
Variants: 10.15 mL cup
Lot Numbers:
20062A (Exp 06/2022)
20067A (Exp 06/2022)
20092A (Exp 09/2022)
20093A (Exp 09/2022)
20101A (Exp 10/2022)
21110A (Exp 10/2022)
20108A (Exp 11/2022)
21012A (Exp 01/2023)
21044A (Exp 04/2023)
21048B (Exp 04/2023)
21053A (Exp 05/2023)
21063B (Exp 06/2023)
21068B (Exp 06/2023)
21084B (Exp 07/2023)
21090A (Exp 08/2023)
21119A (Exp 11/2023)
21122B (Exp 12/2023)
22001B (Exp 01/2024)
22006A (Exp 01/2024)
22017B (Exp 03/2024)
NDC:
0904-6739-71

Packaged in 10 cups per tray, 10 trays per carton. For Institutional Use Only.

Product: Major Pharmaceuticals Acetaminophen Oral Solution (650 mg / 20.3 mL)
Variants: 20.3 mL cup
Lot Numbers:
20064A (Exp 06/2022)
20066A (Exp 06/2022)
20069A (Exp 07/2022)
20073A (Exp 07/2022)
20094A (Exp 09/2022)
20094B (Exp 09/2022)
20095A (Exp 09/2022)
20095B (Exp 09/2022)
20103A (Exp 10/2022)
20105A (Exp 11/2022)
20111A (Exp 12/2022)
20111B (Exp 12/2022)
21005A (Exp 01/2023)
21005B (Exp 01/2023)
21019A (Exp 02/2023)
21019B (Exp 02/2023)
21035A (Exp 03/2023)
21035B (Exp 03/2023)
21038A (Exp 03/2023)
21048A (Exp 04/2023)
21048D (Exp 04/2023)
21058B (Exp 05/2023)
21063A (Exp 06/2023)
21068A (Exp 06/2023)
21084A (Exp 07/2023)
21090B (Exp 08/2023)
21093A (Exp 09/2023)
21124A (Exp 11/2023)
21126A (Exp 11/2023)
21136A (Exp 12/2023)
20112A (Exp 12/2023)
21122A (Exp 12/2023)
21122C (Exp 12/2023)
20112B (Exp 12/2023)
22001A (Exp 01/2024)
22001D (Exp 01/2024)
22006B (Exp 01/2024)
22006C (Exp 01/2024)
22010A (Exp 02/2024)
22011A (Exp 02/2024)
22011B (Exp 02/2024)
22014A (Exp 03/2024)
22015A (Exp 03/2024)
22021A (Exp 03/2024)
NDC:
0904-6820-76

Packaged in 10 cups per tray, 10 trays per carton. For Institutional Use Only.

Product: Major Pharmaceuticals Calcium Carbonate Oral Suspension (1250 mg / 5 mL)
Variants: 5 mL cup
Lot Numbers:
21021A (Exp 02/2023)
21023A (Exp 02/2023)
21024A (Exp 02/2023)
21064A (Exp 06/2023)
21073A (Exp 07/2023)
21075A (Exp 07/2023)
21100A (Exp 09/2023)
21118A (Exp 11/2023)
21120A (Exp 11/2023)
21128A (Exp 12/2023)
21129A (Exp 12/2023)
21131A (Exp 12/2023)
21135A (Exp 12/2023)
22019A (Exp 03/2024)
NDC:
0904-7098-94

Packaged in 10 cups per tray, 4 trays per carton. For Institutional Use Only.

Product: Major Pharmaceuticals Diphenhydramine HCl Oral Solution (12.5 mg / 5 mL)
Variants: 5 mL cup
Lot Numbers:
20063A (Exp 06/2022)
20098A (Exp 10/2022)
21055B (Exp 05/2023)
21066A (Exp 06/2023)
21083B (Exp 07/2023)
21112B (Exp 10/2023)
22009A (Exp 02/2024)
NDC:
0904-6740-70

Packaged in 10 cups per tray, 10 trays per carton. For Institutional Use Only.

Product: Major Pharmaceuticals Diphenhydramine HCl Oral Solution (25 mg / 10 mL)
Variants: 10 mL cup
Lot Numbers:
20065A (Exp 06/2022)
20068A (Exp 07/2022)
20070A (Exp 07/2022)
20097A (Exp 10/2022)
20098A (Exp 10/2022)
21055A (Exp 05/2023)
21083A (Exp 07/2023)
21091A (Exp 08/2023)
21112A (Exp 10/2023)
NDC:
0904-6741-72

Packaged in 10 cups per tray, 10 trays per carton. For Institutional Use Only.

Product: Major Pharmaceuticals Guaifenesin and Dextromethorphan (100 mg-10 mg / 5 mL)
Variants: 5 mL cup
Lot Numbers:
20091A (Exp 09/2022)
20104A (Exp 11/2022)
21013A (Exp 02/2023)
21041A (Exp 04/2023)
21102A (Exp 09/2023)
21121A (Exp 11/2023)
21127A (Exp 11/2023)
22003A (Exp 01/2024)
22007A (Exp 01/2024)
22016A (Exp 03/2024)
NDC:
0904-6844-70

Packaged in 10 cups per tray, 10 trays per carton. For Institutional Use Only.

Product: Major Pharmaceuticals Guaifenesin and Dextromethorphan (200 mg-20 mg / 10 mL)
Variants: 10 mL cup
Lot Numbers:
20091A (Exp 09/2022)
20104A (Exp 11/2022)
21017A (Exp 02/2023)
21034A (Exp 03/2023)
21036A (Exp 03/2023)
21092A (Exp 08/2023)
21105A (Exp 10/2023)
21106A (Exp 10/2023)
21134A (Exp 12/2023)
22007B (Exp 01/2024)
22012A (Exp 02/2024)
22016B (Exp 03/2024)
NDC:
0904-6980-72

Packaged in 10 cups per tray, 10 trays per carton. For Institutional Use Only.

Product: Correct Dose Children's Cough & Chest Congestion DM
Variants: Guaifenesin 100 mg / Dextromethorphan 5 mg per 5 mL, 60 mL (2.04 fl. oz.) pack, 12-5 mL individual doses
UPC Codes:
860003671467
Lot Numbers:
21014A (Exp 02/2023)
NDC:
62320-321-05

Distributed by Correct Dose Inc.

Product: Correct Dose Children's Allergy Relief
Variants: Diphenhydramine HCl 12.5 mg per 5 mL, 60 mL (2.04 fl. oz.) pack, 12-5 mL individual doses
UPC Codes:
860003671443
Lot Numbers:
21011A (Exp 01/2023)
NDC:
62320-302-05

Distributed by Correct Dose Inc.

Product: Correct Dose Children's Pain Relief & Fever Reducer (Cherry)
Variants: Acetaminophen 160 mg per 5 mL, 60 mL (2.04 fl. oz.) pack, 12-5 mL individual doses
UPC Codes:
860003671450
Lot Numbers:
20096A (Exp 10/2022)
NDC:
62320-311-05

Distributed by Correct Dose Inc.

Product Images

Product Insert Major Magnesium hydroxide/Aluminum hydroxide/Simethicone 10x30mL Unit Dose Cups

Product Insert Major Magnesium hydroxide/Aluminum hydroxide/Simethicone 10x30mL Unit Dose Cups

Product Lid, Major Magnesium Hydroxide 1200mg Aluminum Hydroxide 1200mg Simethicone 120mg, For Institutional Use Only

Product Lid, Major Magnesium Hydroxide 1200mg Aluminum Hydroxide 1200mg Simethicone 120mg, For Institutional Use Only

Product Insert Major Magnesium hydroxide/Aluminum hydroxide/Simethicone Max 10x30mL Unit Dose Cups

Product Insert Major Magnesium hydroxide/Aluminum hydroxide/Simethicone Max 10x30mL Unit Dose Cups

Product Lid, Major Magnesium Hydroxide 2400mg Aluminum Hydroxide 2400mg Simethicone 240mg Max, For Institutional Use Only

Product Lid, Major Magnesium Hydroxide 2400mg Aluminum Hydroxide 2400mg Simethicone 240mg Max, For Institutional Use Only

Image 2 - Product Lid, Major Milk of Magnesia Concentrate 2400 mg/10mL, For Institutional Use Only

Image 2 - Product Lid, Major Milk of Magnesia Concentrate 2400 mg/10mL, For Institutional Use Only

Product Lid, Major Milk of Magnesia Concentrate 2400 mg/30mL, For Institutional Use Only

Product Lid, Major Milk of Magnesia Concentrate 2400 mg/30mL, For Institutional Use Only

Product Insert, Major Milk of Magnesia USP, 10 x 30 mL cup

Product Insert, Major Milk of Magnesia USP, 10 x 30 mL cup

Product Insert, Major Milk of Magnesia Concentrate, 10 x 10 mL Unit Does Cups

Product Insert, Major Milk of Magnesia Concentrate, 10 x 10 mL Unit Does Cups

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90398
Status: Resolved
Manufacturer: Plastikon Healthcare LLC
Sold By: Major Pharmaceuticals; Correct Dose Inc; Hospitals; Institutional clinics
Manufactured In: United States
Units Affected: 19 products (24,400 cups; 7,700 cups; 220,500 cups; 43,200 cups; 502,600 cups; 92,200 cups; 521,700 cups; 88,500 cups; 290,270 cups; 848,500 cups; 3,507,740 cups; 49,280 cups; 217,700 cups; 349,100 cups; 280,500 cups; 246,200 cups; 7,200 ampoules; 1,464 ampoules; 1,464 ampoules)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release (1) · FDA Press Release (2) · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.