Lupin Recalls Fayosim Tablets Due to Impurity Test Failures
Lupin Pharmaceuticals is recalling specific lots of Fayosim tablets because they failed impurity specifications during stability testing.
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 that could cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is related to impurity specifications rather than a high-risk pathogen or structural defect.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling 12,464 cartons of Fayosim (levonorgestrel and ethinyl estradiol) tablets USP and ethinyl estradiol tablets USP. The affected products are packaged in 1 Extended-Cycle Wallet of 91 Tablets. The recall covers lots L800016 (Exp 12/2019) and L800721 (Exp 05/2020).
The recall was initiated due to failed impurities and degradation specifications. Out-of-specification results were observed in the related substance test, specifically for any other individual impurity and total impurities, in the Ethinyl Estradiol Tablets USP 0.01mg during a 12-month long-term stability study.
The affected products were distributed nationwide in the USA. Consumers should check their medication for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, consumers should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets USP, (0.01 mg), packaged in 1 Extended-Cycle Wallet of 91 Tablets packed in a pouch(NDC 68180-860-11); one pouch per carton (NDC 68180-86
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Oral Contraceptive
- Hazard
- Affected units
- 12,464
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 (4)
- Lot #: L800016
- Exp 12/2019
- L800721
- Exp 05/2020
Distribution
Distributed nationwide across the United States.
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