Lupin Recalls My Way Emergency Contraception Tablets for Lack of Approval
Lupin Pharmaceuticals is recalling My Way emergency contraception tablets because the 2-pack configuration was marketed without the required regulatory approval.
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 indicates a temporary or medically reversible adverse health consequence. The specific hazard is a regulatory compliance issue (lack of approval) rather than a direct physical defect or contamination, fitting the Moderate severity criteria for minor labeling or regulatory errors.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each. The product is packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton and is manufactured by GAVIS Pharmaceuticals, a Lupin Group Company, for Lupin Pharmaceuticals, Inc. in Baltimore, MD.
The recall was initiated because the 2-pack configuration was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The specific configuration did not receive appropriate regulatory approval prior to its release.
Approximately 43,922 cartons of the product were distributed nationwide in the USA. The affected lots are M16317A1, M16317A4, and M16317A5, all with an expiration date of 11/18. The product carries the UPC 3 43386-622-31 3.
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, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, UPC 3 43386-622-31 3.
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Emergency Contraception
- Affected units
- 43,922
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 (4)
- Lot #: M16317A1
- M16317A4
- M16317A5
- Exp 11/18
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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