“Recall: Pharmaceutical Associates Guaifenesin & Codeine Oral Solution.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32336-recall-pharmaceutical-associates-guaifenesin-codeine-oral-solution. Based on FDA recall #D-0222-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0222-2025%22&limit=1).
The FDA announced on Jan. 7, 2025, that PAI Holdings LLC dba Pharmaceutical Associates Inc voluntarily recalled Guaifenesin and Codeine Phosphate Oral Solution due to superpotency and sodium benzoate preservative hazards. The Class III recall involves 4,080 bottles distributed in Ohio.
How to tell if you have it
Brand: Pharmaceutical Associates
Product: Guaifenesin Codeine Oral Solution
NDC: 0121-0775-16
Lot number: 4B07
Exp Date: 2026-OCT-31
Size: 16 fl oz (473 ml) bottles
The hazard
The recall addresses superpotency and the presence of a sodium benzoate preservative in Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL. The FDA classified this as a Class III recall.
Context
GovInfoNow's records show PAI Holdings LLC dba Pharmaceutical Associates Inc has four other recalls on record since March 19, 2020. Other recent recalls of similar products include Shoolin Pharma Chem Tadalafil Recall (Aug. 3, 2026), Wells Pharma Fentanyl Citrate Injectable Solution Recall (April 1, 2026), and Wells Pharma Fentanyl Citrate Solution Recall (April 1, 2026).
How to tell if you have this one
Check your medication bottle for the brand PAI (Pharmaceutical Associates). Look for NDC 0121-0775-16 and Lot number 4B07. The bottle size is 16 fl oz (473 ml) and the expiration date is listed as 2026-OCT-31.
Brand
Pharmaceutical Associates
Category
Drug
Based on the official FDA remedy
What to do — step by step
Stop using the medication
Do not consume any more of this specific lot due to the labeling discrepancy.
Contact your pharmacy or doctor
Reach out to the provider who prescribed or sold the medication for instructions on replacement or disposal.
Where it went and when
Where it was distributed
Distributed in Ohio.
Listed by the agency
Not listed
FDA distribution: “OH” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Ohio.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0222-2025 (January 7, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0222-2025 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.