CLASS III Drug recall · Reported 12 Feb 2025 · FDA Enforcement Report
Guaifenesin and Codeine Phosphate Oral Solution recalled by PAI Holdings
PAI Holdings is recalling Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per, PAI Pharmaceutical, distributed in Ohio. The recall was initiated on 7 Jan 2025 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0222-2025
- FDA event ID
- 96119
- Recalling firm
- PAI Holdings, Greenville, SC
- Manufacturer
- PAI Holdings, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Jan 2025
- FDA classified
- 4 Feb 2025
- Reported
- 12 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Cold & Cough Medicine
Timeline
| 7 Jan 2025 | Recall initiated by company | |
| 4 Feb 2025 | Classified by FDA | +28 days |
| 12 Feb 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent; sodium benzoate preservative
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
OH
Questions about this recall
Is Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per, PAI Pharmaceutical recalled?
Yes. PAI Holdings recalled Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per, PAI Pharmaceutical on 7 Jan 2025. The recall is Class III and its status is Terminated. Recall number D-0222-2025.
Why was it recalled?
Superpotent; sodium benzoate preservative
Which lots are affected?
Lot number 4B07, Exp Date: 2026-OCT-31
Where was it sold?
OH
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from PAI Holdings
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | VistaPharm, Kerr Insta-char IN AN Sorbitol Base With Cherry recalled | PAI Holdings | Other | Nationwide |
| Drug | CLASS II | VistaPharm, Kerr Insta-char IN AN Aqueous Base With Cherry recalled | PAI Holdings | Other | Nationwide |
| Drug | CLASS II | VistaPharm, Kerr Insta-char IN AN Sorbitol Base With Cherry recalled | PAI Holdings | Other | Nationwide |
| Drug | CLASS II | VistaPharm, Kerr Insta-char IN AN Aqueous Base With Cherry recalled | PAI Holdings | Other | Nationwide |
| Drug | CLASS II | Nystatin Oral Suspension, USP per mL, Cherry/Peppermint Flavor recalledNystatin | PAI Holdings | Manufacturing (CGMP) Deviations | Nationwide |
Other Guaifenesin recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Guaifenesin Oral Solution, 300 mg/, Sugar Free/Alcohol Free recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Rompe Pecho Ex Expectorant recalled by Efficient LaboratoriesRompe Pecho | Efficient Laboratories | Sterility | Nationwide |
| Drug | CLASS III | Mucinex DM (guaifenesin 600mg recalled by Reckitt BenckiserMucinex Dm | Reckitt Benckiser | Packaging Defects | Nationwide |
| Drug | CLASS II | Guaifenesin USP Drums, CAS No. 93-14-1, Reg recalled | Traxx International | Foreign Material | Nationwide |