My Way — Class II drug recall D-0838-2018
Terminated recall by Lupin Pharmaceuticals Inc., reported 2018-05-30, distributed nationwide. Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval pr
| Recall number | D-0838-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2018-05-17 |
| Classified | 2018-05-31 |
| Reported by FDA | 2018-05-30 |
| Terminated | 2019-05-01 |
| Distributed | Nationwide (US) |
| Quantity | 43,640 cartons |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 00368180852124 |
| Lot numbers | 08/19, 11/19, L700329, L700670 |
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 85212 4.
Reason for recall
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0838-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.