Lupin Recalls Kaitlib Fe Tablets Due to Stability Test Failures
Lupin Pharmaceuticals is recalling Kaitlib Fe chewable tablets because long-term stability testing showed out-of-specification impurities or degradation.
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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving potential but unreported harm.
Plain-English summary
Lupin Pharmaceuticals, Inc. is recalling Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets. The recall involves 12,938 units of the product, which is distributed nationwide in the USA. The specific lot number is L800050, and the product is available in wallet and carton packaging.
The recall was initiated because the product failed impurities and degradation specifications. Specifically, an out-of-specification result was observed in a long-term stability study. This indicates that the product may not meet the required quality standards over time.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The product is prescription-only, so patients should consult their prescriber regarding alternative treatments or next steps.
The recalled product
- Product
- Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, MD - 21202 Manufactured by: Lupin Limited Pathampur -454775 India. NDC 68180-903-11 (wallet…
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Oral Contraceptive
- Hazard
- Affected units
- 12,938
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 (1)
- Lot L800050
Distribution
Distributed nationwide across the United States.
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