🔍 RecallPedia

Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16

Class I - Dangerous
💊 Drugs Recalled: January 7, 2025 PAI Holdings, LLC. Prescription Drugs

What Should You Do?

  1. Check if you have this product:
    Lot number 4B07, Exp Date: 2026-OCT-31
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Reason for Recall:
Superpotent; sodium benzoate preservative
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16

Product Codes/Lot Numbers:

Lot number 4B07, Exp Date: 2026-OCT-31

Distribution:

Distributed in: OH

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0222-2025

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