FDA recall D-0007-2026

AvKARE · Class II · drug

Product

Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister cards per carton, Rx only, Manufactured for AvKARE, Pulaski, TN 38478. Carton NDC: 42291-565-84; Blister NDC: 42291-565-28

Reason for recall

Failed Content Uniformity Specifications

Distribution

U.S. Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-09-02
Report date: 2025-10-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0007-2026