Warning
ANI Pharmaceuticals Recalls Estradiol Gel
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0543-2026Drug / Pharmaceutical
ANI Pharmaceuticals Recalls Estradiol Gel
ANI Pharmaceuticals, Inc. · Class II — Moderate Risk
Product Description
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide in the USA
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
ANI Pharmaceuticals, Inc. has recalled a pharmaceutical product that the FDA classified as Class II affecting 3964 Cartons. The recall was initiated on May 12, 2026. Defective Container; packets were found to be either empty or partially full. It was distributed nationwide. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.