FDA recall D-0543-2026

Product

Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20

Reason for recall

Defective Container; packets were found to be either empty or partially full.

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2026-05-12

Report date

2026-05-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baudette, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0543-2026