Oral contraceptive tablets recalled after failing content uniformity specifications
AvKARE is recalling 2,192 cartons of Norgestimate and Ethinyl Estradiol Tablets USP from one lot after the product failed content uniformity specifications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: failed content uniformity means individual tablets may not deliver the labeled dose of a daily medicine, and no injuries are reported.
Plain-English summary
Norgestimate and Ethinyl Estradiol Tablets, USP, at 0.18 mg/0.025 mg, 0.215 mg/0.025 mg and 0.25 mg/0.025 mg, supplied as three 28-tablet blister cards per carton and manufactured for AvKARE of Pulaski, Tennessee, are being recalled for failed content uniformity specifications.
Content uniformity governs how consistently the active ingredient is distributed across tablets, so a failure means individual tablets may not contain the labeled amount.
The recall covers 2,192 cartons from lot LF41138A, expiring 30 June 2027, carrying carton NDC 42291-565-84. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
This is a prescription medicine taken on a daily schedule, so patients holding the affected lot should contact their pharmacy or prescriber about a replacement rather than stopping on their own.
The recalled product
- Product
- NORGESTIMATE AND ETHINYL ESTRADIOL (NORGESTIMATE AND ETHINYL ESTRADIOL)
- Brand
- NORGESTIMATE AND ETHINYL ESTRADIOL
- Manufacturer
- AvKARE
- Category
- Drug — Contraceptive
- Affected units
- 2,192
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # LF41138A
- Exp 06/30/2027
Distribution
Distributed nationwide across the United States.
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