D-0222-2025Class III

PAI Holdings, LLC. dba Pharmaceutical Associates Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Drug

Status

Terminated

Report date

2025-02-12

Distribution

Firm state

Product quantity

4080 Bottles

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Validation & Qualification

Reason for recall

Superpotent; sodium benzoate preservative

Product description

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

Code / lot info

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

Other recalls SPEQ maps to Validation & Qualification

2026-10-21Class IIZydus Pharmaceuticals (USA) Inc 2026-10-21Class IIIMagellan Diagnostics, Inc.2026-10-21Class IIMicrogenics Corporation 2026-10-14Class IICipla USA, Inc.

See all Validation & Qualification recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →