Lupin Recalls My Way Levonorgestrel Tablets for Lack of Approved NDA
Lupin Pharmaceuticals is recalling My Way (levonorgestrel) emergency contraception tablets because the 2-pack configuration was marketed without an approved New Drug Application.
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 due to a regulatory compliance issue (marketed without an approved NDA/ANDA) rather than a direct physical hazard like contamination or injury. This falls under the 'Minor labeling errors' or 'voluntary precautionary recalls' category for moderate severity, as there are no reported illnesses or injuries associated with the product itself.
Plain-English summary
Lupin Pharmaceuticals Inc. is voluntarily recalling lots of My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each. The product consists of two 1.5mg levonorgestrel tablets per carton, manufactured by Lupin Limited in India for Lupin Pharmaceuticals Inc. in Baltimore, MD.
The recall is necessary because the specific 2-pack configuration was marketed without receiving appropriate regulatory approval (an approved New Drug Application or Abbreviated New Drug Application) prior to release.
Affected products include 43,640 cartons distributed nationwide in the USA. The recalled lots are L700329 (expiration date 08/19) and L700670 (expiration date 11/19), identified by UPC 3 68180 85212.
Consumers who have purchased these products should check their lot numbers and expiration dates. If you possess the affected lots, you should stop using them and contact Lupin Pharmaceuticals or a healthcare provider for further instructions.
The recalled product
- Product
- My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454 775, INDIA, UPC 3 68180…
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Emergency Contraception
- Hazard
- Affected units
- 43,640
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 #: L700329
- Exp 08/19
- L700670
- Exp 11/19
Distribution
Distributed nationwide across the United States.
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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