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.
What this means for you
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, NDC
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Oral Contraceptive
- Hazard
- 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.
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