Drug recall
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…
FDA recall event 97542 · Class II · AvKARE
Key facts
| Event ID | 97542 |
|---|---|
| Recall numbers | D-0007-2026 |
| Recalling firm | AvKARE |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Content Uniformity Specifications |
| Initiation date | Sep 2, 2025 |
| Report date | Oct 15, 2025 |
| City | Pulaski |
| State | TN |
| Country | United States |
| FEI number | 3007255004 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: