Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1502-2020·Announced 2020-08-19

Lupin Recalls Mibelas 24 Fe Tablets Due to Impurity Test Failures

Lupin Pharmaceuticals is recalling Mibelas 24 Fe chewable tablets because they failed impurity specifications. The recall covers 560,922 pouches distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. No specific injuries or illnesses are reported in the source text.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable tablets. The recall is being conducted because out-of-specification results were observed in the related substance test, indicating a failure of impurities or degradation specifications.

The affected product is a prescription-only medication that provides 24 days of active therapy. The recall includes 560,922 pouches, which were distributed nationwide within the United States. Specific lot numbers and expiration dates are listed in the official recall documentation.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on next steps. The product was manufactured by Lupin Limited in India and distributed by Lupin Pharmaceuticals, Inc.

The recalled product

Product: Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/75 mg, Rx Only, Provides 24 days of active therapy, Pouch Contains one wallet of 28 tablets, NDC: 68180-911-11, Carton contains 3 wallets of 28 tablets each…
Manufacturer: Lupin Pharmaceuticals Inc.
Category: Drug — Oral Contraceptive
Hazard: impurity
degradation
Affected units: 560,922

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 (12)

Lot #s: L900017
L900070
Exp. 12/31/2020
L900589
Exp. 03/31/2021
L901085
Exp. 04/30/2021
L901008
Exp. 06/30/2021
L901641
L901735
Exp.10/31/2021.

Distribution

Distributed nationwide across the United States.

Same manufacturer · Lupin Pharmaceuticals Inc.

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