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
Reported: October 15, 2025 Initiated: September 2, 2025 #D-0007-2026
Product Description
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
Details
- Recalling Firm
- AvKARE
- Units Affected
- 2192 cartons
- Distribution
- U.S. Nationwide
- Location
- Pulaski, TN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by AvKARE. Units affected: 2192 cartons.
Why was this product recalled? ▼
Failed Content Uniformity Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 15, 2025. Severity: Moderate. Recall number: D-0007-2026.
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