Medications & Supplements/Over-the-Counter

Geritrex, LLC: OTC Liquid Medications Recalled for Possible Microbial Contamination

Agency Publication Date: July 25, 2019

Summary

Approximately 56,871 bottles of various over-the-counter liquid medications, including Diphenhydramine (Benadryl), Ritussin DM, and Iron supplements, have been recalled due to concerns about microbial contamination and manufacturing violations. These products include common stool softeners, cough syrups, and iron elixirs sold nationwide in 4 fl. oz. and 16 fl. oz. bottles. The recall was initiated because the products may contain harmful bacteria, which can lead to serious infections, especially in vulnerable populations.

Risk

The medications may be contaminated with microbes due to manufacturing deviations. Ingesting contaminated oral liquids can cause severe infections or illness, particularly for children, the elderly, or individuals with weakened immune systems.

What You Should Do

Check your medicine cabinet for Diphenhydramine Oral Liquid (12.5 mg/5 mL) in 4 fl. oz. bottles with lot 70606 (Exp 6/19).
Check for Ritussin DM Children & Adults or Double Strength in 4 fl. oz. bottles with lot numbers 70602 or 70611 (Exp 6/19).
Check for Gericare or Preferred Plus Iron Elixir (220 mg) in 16 fl. oz. bottles with lot 70601 (Exp 6/19).
Check for Gericare Diocto or Preferred Plus Dioctyl Stool Softener (50 mg/5mL) in 16 fl. oz. bottles with lot numbers 70603, 70604, 70612, or 70612 (Exp 6/19).
Stop using these products immediately and contact your healthcare provider or pharmacist for guidance regarding your health and alternative treatments.
Return any unused product to the pharmacy or place of purchase for a full refund and contact Geritrex, LLC for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Refund and medical consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL (4 fl oz)

Model:

NDC 53807-204-04

Lot Numbers:

70606 (Exp 6/19)

Product: Ritussin DM Children & Adults (4 fl oz)

Model:

NDC 53807-409-04

Lot Numbers:

70602 (Exp 6/19)

Product: Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL (16 fl oz)

Model:

NDC 57896-403-16

Lot Numbers:

70612 (Exp 6/19)

Product: Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg (16 fl oz)

Model:

NDC 57896-709-16

Lot Numbers:

70601 (Exp 6/19)

Product: Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg (16 fl oz)

Model:

NDC 52807-177-16

Lot Numbers:

70601 (Exp 6/19)

Product: Ritussin DM Double Strength (4 fl oz)

Lot Numbers:

70611 (Exp 6/19)

Product: Gericare Geri-Tussin DM (16 fl oz)

Model:

NDC 57896-660-16

Lot Numbers:

70602 (Exp 6/19)

Product: Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL (16 fl oz)

Model:

NDC 53807-216-16

Lot Numbers:

70603 (Exp 6/19)

70604 (Exp 6/19)

70612 (Exp 6/19)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83200

Status: Resolved

Manufacturer: Geritrex, LLC

Sold By: Preferred Plus Pharmacy; Gericare Pharmaceuticals corp; Kinray Inc; RIJ Pharmaceutical Corporation

Manufactured In: United States

Units Affected: 8 products (8645 bottles; 5107 bottles; 6165 bottles; 3789 bottles; 3864 bottles; 7653 bottles; 6213 bottles; 15435 bottles)

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 · 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.

Summary

What You Should Do

Check your medicine cabinet for Diphenhydramine Oral Liquid (12.5 mg/5 mL) in 4 fl. oz. bottles with lot 70606 (Exp 6/19).

Check for Ritussin DM Children & Adults or Double Strength in 4 fl. oz. bottles with lot numbers 70602 or 70611 (Exp 6/19).

Check for Gericare or Preferred Plus Iron Elixir (220 mg) in 16 fl. oz. bottles with lot 70601 (Exp 6/19).

Check for Gericare Diocto or Preferred Plus Dioctyl Stool Softener (50 mg/5mL) in 16 fl. oz. bottles with lot numbers 70603, 70604, 70612, or 70612 (Exp 6/19).

Stop using these products immediately and contact your healthcare provider or pharmacist for guidance regarding your health and alternative treatments.

Return any unused product to the pharmacy or place of purchase for a full refund and contact Geritrex, LLC for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL (4 fl oz)

Model:

NDC 53807-204-04

Lot Numbers:

70606 (Exp 6/19)

Product: Ritussin DM Children & Adults (4 fl oz)

Model:

NDC 53807-409-04

Lot Numbers:

70602 (Exp 6/19)

Product: Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL (16 fl oz)

Model:

NDC 57896-403-16

Lot Numbers:

70612 (Exp 6/19)

Product: Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg (16 fl oz)

Model:

NDC 57896-709-16

Lot Numbers:

70601 (Exp 6/19)

Product: Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg (16 fl oz)

Model:

NDC 52807-177-16

Lot Numbers:

70601 (Exp 6/19)

Product: Ritussin DM Double Strength (4 fl oz)

Lot Numbers:

70611 (Exp 6/19)

Product: Gericare Geri-Tussin DM (16 fl oz)

Model:

NDC 57896-660-16

Lot Numbers:

70602 (Exp 6/19)

Product: Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL (16 fl oz)

Model:

NDC 53807-216-16

Lot Numbers:

70603 (Exp 6/19)

70604 (Exp 6/19)

70612 (Exp 6/19)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83200

Status: Resolved

Manufacturer: Geritrex, LLC

Sold By: Preferred Plus Pharmacy; Gericare Pharmaceuticals corp; Kinray Inc; RIJ Pharmaceutical Corporation

Manufactured In: United States

Units Affected: 8 products (8645 bottles; 5107 bottles; 6165 bottles; 3789 bottles; 3864 bottles; 7653 bottles; 6213 bottles; 15435 bottles)

Distributed To: Nationwide