FDAClass IIIFebruary 12, 2025

Guaifenesin and Codeine Phosphate Oral Solution USP recall: Superpotent

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

Why was Guaifenesin and Codeine Phosphate Oral Solution USP recalled?

Superpotent; sodium benzoate preservative

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville…
Recalling firm
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Quantity
4080 Bottles
Distribution
OH
Recall date
February 12, 2025
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls