Norgestimate and Ethinyl Estradiol Tablets recall
FDA recall D-0007-2026 · initiated Sep 2, 2025
AvKARE recalled Norgestimate and Ethinyl Estradiol Tablets in Sep 2025 — an FDA Class II recall (D-0007-2026) because Failed Content Uniformity Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Content Uniformity Specifications
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2192 cartons
Details
- 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
- Recalling company
- AvKARE
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- Sep 2, 2025
- FDA report date
- Oct 15, 2025
This recall is linked to a product we cover: Tri-Lo-Estarylla →
Frequently asked
- Was Norgestimate and Ethinyl Estradiol Tablets recalled?
- AvKARE recalled Norgestimate and Ethinyl Estradiol Tablets in Sep 2025 — an FDA Class II recall (D-0007-2026) because Failed Content Uniformity Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Norgestimate and Ethinyl Estradiol Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0007-2026 was: Failed Content Uniformity Specifications
- Is a recalled Norgestimate and Ethinyl Estradiol Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Norgestimate and Ethinyl Estradiol Tablets are affected?
- Distributed: U.S. Nationwide. The recall covers these lots — Lot # LF41138A; Exp 06/30/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0007-2026.