Lupin Recalls Levonorgestrel and Ethinyl Estradiol Tablets for Content Uniformity
Lupin Pharmaceuticals is recalling specific lots of oral contraceptive tablets due to failed content uniformity tests.
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 that might cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is a quality control failure (content uniformity) rather than a high-risk pathogen or structural defect.
Plain-English summary
Lupin Pharmaceuticals, Inc. is recalling Levonorgestrel and Ethinyl Estradiol Tablets USP in three strengths: 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg. The affected products are packaged in 1 Wallet of 28 Tablets (NDC 68180-857-11) and 3 Wallets of 28 Tablets Each per carton (NDC 68180-857-13). The recall involves 9,897 cartons of Lot # L800951, which has an expiration date of July 2020.
The recall was initiated because the product failed Content Uniformity Specifications, resulting in out-of-specification test results. The agency has classified this recall as Class II.
The affected products were distributed nationwide in the USA and Puerto Rico. Consumers and healthcare providers should check their inventory for the specific NDCs and lot number listed above. If the product is found, it should be returned to the pharmacy or supplier for credit or replacement.
The recalled product
- Product
- Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wallet of 28 Tablets (NDC 68180-857-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-857-13); Rx Only, Distributed by: Lupin Pharmaceuticals, Inc.…
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Oral Contraceptives
- Hazard
- Affected units
- 9,897
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 #: L800951
- Exp July 2020
Distribution
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.
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