Requests from the FDA the immediate and complete withdrawal of Wells Pharma’s Compounded Indomethacin 100 mg Rectal Suppository due to false marketing and unacceptable immunological safety risks. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2025-P-5921

Requests from the FDA the immediate and complete withdrawal of Wells Pharma’s Compounded Indomethacin 100 mg Rectal Suppository due to false marketing and unacceptable immunological safety risks.

Documents

Comments

Key Dates

Comment Period OpensNov 7, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Interim Response Letter from FDA CDER to Wiley Rein LLP	Apr 28, 2026	--

Keywords

CDER

Citizen Petition

Wiley Rein LLP

the immediate and

complete withdrawal of Wells Pharma s Compounded

Indomethacin 100 mg Rectal Suppository

due to false marketing

and unacceptable immunological safety risks

Data from Regulations.gov