AvKARE: Drug Recall

Recall #D-0007-2026 · 09/02/2025

Class II: Risk

Recall Details

Recall Number
D-0007-2026
Classification
Class II
Product Type
Drug
Recalling Firm
AvKARE
Status
Ongoing
Date Initiated
09/02/2025
Location
Pulaski, TN, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2192 cartons

Reason for Recall

Failed Content Uniformity Specifications

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

Distribution Pattern

U.S. Nationwide

Other Recalls by AvKARE

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.