Guaifenesin and Codeine Cough Syrup Recalled for Superpotent Strength
PAI Pharmaceutical Associates is recalling Guaifenesin and Codeine Phosphate Oral Solution because the product contains higher-than-labeled active ingredient concentrations. The affected product was distributed in Ohio.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with no reported illnesses or injuries. The product is superpotent (higher active ingredient concentration than labeled), which poses a theoretical dosing concern but aligns with Class III precautionary recalls.
Plain-English summary
PAI Holdings, LLC, doing business as Pharmaceutical Associates Inc, is recalling Guaifenesin and Codeine Phosphate Oral Solution USP (100 mg/10 mg per 5 mL) distributed in Ohio. The affected product is sold in 16 fl oz bottles (NDC 0121-0775-16). Approximately 4,080 bottles of Lot Number 4B07 with an expiration date of October 31, 2026 are affected.
The product is superpotent, meaning the active ingredient concentration is higher than labeled. Codeine phosphate is an opioid cough suppressant, and guaifenesin is an expectorant. The higher-than-labeled concentrations may pose a dosing concern.
Consumers who have this product should stop using it immediately and consult a healthcare provider or contact Poison Control with any questions or concerns. The FDA recall number is D-0222-2025.
The recalled product
- Product
- GUAIFENESIN AND CODEINE PHOSPHATE (GUAIFENESIN AND CODEINE PHOSPHATE)
- Brand
- GUAIFENESIN AND CODEINE PHOSPHATE
- Manufacturer
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Hazard
- strength-mislabeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot number 4B07
- Exp Date: 2026-OCT-31
Distribution
Distributed in 1 state:
- OH
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