Guaifenesin Codeine Solution (PAI Holdings) – Superpotent Preservative (2025)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Lot Codes / Batch Numbers
Lot number 4B07, Exp Date: 2026-OCT-31
Products Sold
Lot number 4B07, Exp Date: 2026-OCT-31
PAI Holdings, LLC. dba Pharmaceutical Associates Inc is recalling Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles due to Superpotent; sodium benzoate preservative. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Superpotent; sodium benzoate preservative
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
OH
Page updated: Jan 7, 2026