Norgestimate and Ethinyl Estradiol Tablets — Class II drug recall D-0007-2026
Ongoing recall by AvKARE, reported 2025-10-15, distributed nationwide. Failed Content Uniformity Specifications
| Recall number | D-0007-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AvKARE, Pulaski, TN, United States |
| Recall initiated | 2025-09-02 |
| Classified | 2025-10-06 |
| Reported by FDA | 2025-10-15 |
| Distributed | Nationwide (US) |
| Quantity | 2,192 cartons |
| NDC | 42291-0565, 42291-0565-28, 42291-0565-84 |
| Lot numbers | LF41138A |
| Expiration dates | 2027-06-30 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0007-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.