September 2025 FDA Recall Norgestimate And Ethinyl Estradiol by Avkare
D-0007-2026 - Failed Content Uniformity Specifications
This Class II drug recall was voluntarily initiated by Avkare on September 2, 2025 for the product Norgestimate And Ethinyl Estradiol. The FDA reported the reason for recall as failed content uniformity specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0007-2026
Failed Content Uniformity Specifications
09-02-2025
10-15-2025
2192 cartons
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
AvKARE
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# LF41138A; Exp 06/30/2027
