Guaifenesin and Codeine Phosphate Oral Solution USP recall
FDA recall D-0222-2025 · initiated Jan 7, 2025
PAI Holdings, LLC. dba Pharmaceutical Associates Inc recalled Guaifenesin and Codeine Phosphate Oral Solution USP in Jan 2025 — an FDA Class III recall (D-0222-2025) because Superpotent; sodium benzoate preservative.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Superpotent; sodium benzoate preservative
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4080 Bottles
Details
- 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, SC 29605, NDC 0121-0775-16
- Recalling company
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Classification
- Class III
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- OH
- Initiated
- Jan 7, 2025
- FDA report date
- Feb 12, 2025
Frequently asked
- Was Guaifenesin and Codeine Phosphate Oral Solution USP recalled?
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc recalled Guaifenesin and Codeine Phosphate Oral Solution USP in Jan 2025 — an FDA Class III recall (D-0222-2025) because Superpotent; sodium benzoate preservative. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Guaifenesin and Codeine Phosphate Oral Solution USP recalled?
- Per the FDA enforcement record, the reason for recall D-0222-2025 was: Superpotent; sodium benzoate preservative
- Is a recalled Guaifenesin and Codeine Phosphate Oral Solution USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Guaifenesin and Codeine Phosphate Oral Solution USP are affected?
- Distributed: OH. The recall covers these lots — Lot number 4B07, Exp Date: 2026-OCT-31. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0222-2025.