Home / Recalls / AvKARE / D-0007-2026

D-0007-2026 Class II Ongoing

Recalled by AvKARE — Pulaski, TN

Recall Details

Product Type
Drugs
Report Date
October 15, 2025
Initiation Date
September 2, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2192 cartons

Product Description

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 Pattern

U.S. Nationwide

Code Information

Lot # LF41138A; Exp 06/30/2027

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  • D-0224-2025 Class II — Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufa (January 21, 2025)