Oral contraceptive tablets recalled after failing content uniformity specifications

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

Hazard

• content-uniformity
• out-of-specification
• dose-variability

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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