Agency classClass IIIOur severity:Low FDA (Drugs)·D-1055-2020·Announced 2020-03-18

Lupin Recalls Bekyree Tablets Due to Content Uniformity Failures

Lupin Pharmaceuticals is recalling specific lots of Bekyree oral contraceptives because they failed content and blend uniformity tests.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which indicates the product is unlikely to cause adverse health consequences. The issue is a manufacturing specification failure (content uniformity) without reported injuries or illnesses.

Plain-English summary

Lupin Pharmaceuticals Inc. is voluntarily recalling 1,712 cartons of Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg). The affected product is packaged in 1 Wallet of 28 Tablets (NDC 68180-879-11) or 3 Wallets of 28 Tablets Each per carton (NDC 68180-879-13). The specific lot number is L800915, with an expiration date of July 2020.

The recall was initiated because the product failed Content Uniformity Specifications, specifically showing out-of-specification test results for content and blend uniformity. This means the tablets may not contain the intended amount of active ingredients in a consistent manner.

The affected product was distributed nationwide in the USA and Puerto Rico. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for guidance on alternative contraception. The product is prescription-only.

The recalled product

Product: Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet of 28 Tablets (NDC 68180-879-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-879-13), Rx Only, Distributed by: Lupin Pharmaceuticals…
Manufacturer: Lupin Pharmaceuticals Inc.
Category: Drug — Oral Contraceptive
Hazard: content-uniformity
blend-uniformity
Affected units: 1,712

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 #: L800915
Exp July 2020

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Lupin Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Lupin Pharmaceuticals Inc.

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