Reported Feb 12, 2025 · Terminated

Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI…

PAI Holdings, LLC. dba Pharmaceutical Associates Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: PAI Holdings, LLC. dba Pharmaceutical Associates Inc · 1700 Perimeter Rd · Greenville, SC · 29605-5252

Is this the product you have?

  • 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
Lot codes and dates
  • Lot number 4B07
  • Exp Date2026-OCT-31
Amount recalled
4080 Bottles

Where it was sold

Why it was recalled

Superpotent; sodium benzoate preservative

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 25, 2026 · Data as of Sep 19, 8:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.