Medications & Supplements/Prescription Drugs

Pharmaceutical Associates Guaifenesin and Codeine Recalled for Superpotency

Agency Publication Date: February 4, 2025

Summary

PAI Holdings, LLC, doing business as Pharmaceutical Associates Inc, is recalling 4,080 bottles of Guaifenesin and Codeine Phosphate Oral Solution USP (100mg/10 mg per 5 mL). This cough and congestion medication is being recalled because it contains excessive levels of the preservative sodium benzoate. The recall affects 16 fl oz (473 ml) bottles from lot 4B07 with an expiration date of October 31, 2026.

Risk

The medication was found to be superpotent in the preservative sodium benzoate. While the health risk is categorized as low, using a product with incorrect ingredient levels could lead to unexpected side effects or reduced safety.

What You Should Do

This recall affects 16 fl oz (473 ml) bottles of Guaifenesin and Codeine Phosphate Oral Solution USP (100mg/10 mg per 5 mL) sold under the PAI Pharmaceutical Associates, Inc. brand with NDC 0121-0775-16.
Identify if your product is affected by checking the label for lot number 4B07 and the expiration date 2026-OCT-31.
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 the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for 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 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: Guaifenesin and Codeine Phosphate Oral Solution USP (16 fl oz)by PAI Pharmaceutical Associates, Inc.

Variants: 100mg/10 mg per 5 mL

Lot Numbers:

4B07 (Exp 2026-OCT-31)

NDC:

0121-0775-16

Manufactured by PAI Pharmaceutical Associates, Inc., Greenville, SC 29605

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96119

Status: Resolved

Manufacturer: PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Manufactured In: United States

Units Affected: 4080 Bottles

Distributed To: Ohio

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

This recall affects 16 fl oz (473 ml) bottles of Guaifenesin and Codeine Phosphate Oral Solution USP (100mg/10 mg per 5 mL) sold under the PAI Pharmaceutical Associates, Inc. brand with NDC 0121-0775-16.

Identify if your product is affected by checking the label for lot number 4B07 and the expiration date 2026-OCT-31.

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 the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.