Class II
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 Units, 3x28 tablets blister cards per carton, Rx only, Manufactured for AvKARE, Pulaski,
AvKARE · September 2, 2025
Reason for Recall
Failed Content Uniformity Specifications
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
Distribution
U.S. Nationwide
States Affected
NATIONWIDE
Quantity Affected
2192 cartons
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0007-2026
Status: ongoing
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