CLASS II ONGOING Drug recall · Reported 15 Oct 2025 · FDA Enforcement Report
Norgestimate and Ethinyl Estradiol Tablets recalled by AvKARE
AvKARE is recalling Norgestimate and Ethinyl Estradiol Tablets, USP, 18 mg/0.025 mg, 215 mg/0.025 mg, and 25, distributed nationwide in the US. The recall was initiated on 2 Sep 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0007-2026
- FDA event ID
- 97542
- Recalling firm
- AvKARE, Pulaski, TN
- Manufacturer
- AvKARE
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Sep 2025
- FDA classified
- 6 Oct 2025
- Reported
- 15 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Hormones & Birth Control
Timeline
| 2 Sep 2025 | Recall initiated by company | |
| 6 Oct 2025 | Classified by FDA | +34 days |
| 15 Oct 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Content Uniformity Specifications
Product as listed by the FDA
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
Where it was distributed
U.S. Nationwide
Questions about this recall
Is Norgestimate and Ethinyl Estradiol Tablets, USP, 18 mg/0.025 mg, 215 mg/0.025 mg, and 25 recalled?
Yes. AvKARE recalled Norgestimate and Ethinyl Estradiol Tablets, USP, 18 mg/0.025 mg, 215 mg/0.025 mg, and 25 on 2 Sep 2025. The recall is Class II and its status is Ongoing. Recall number D-0007-2026.
Why was it recalled?
Failed Content Uniformity Specifications
Which lots are affected?
Lot # LF41138A; Exp 06/30/2027
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from AvKARE
All 57| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amantadine HCl, Capsules, UPS, 100 mg dose recalled by AvKAREAmantadine Hcl | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Rosuvastatin Tablets, USP, 10 mg recalled by AvKARERosuvastatin | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | chloroproMAZINE Hydrochloride Tablets, USP, 100 mg unit dose recalledChlorpromazine Hydrochloride | AvKARE | Other | Nationwide |
| Drug | CLASS II | chloroproMAZINE Hydrochloride Tablets, USP, 50 mg unit dose recalledChlorpromazine Hydrochloride | AvKARE | Other | Nationwide |
| Drug | CLASS III | Pitavastatin Tablets, 2 mg recalled by AvKAREPitavastatin | AvKARE | Potency & Assay | Nationwide |
Other Norgestimate recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tri-Lo-Sprintec (norgestimate recalled by Teva Pharmaceuticals USATri-lo-sprintec | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Tri-lo-marzia 180mg/0.025mg recalled by Cardinal HealthTri-lo-marzia | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |