Levonorgestrel and Ethinyl Estradiol Tablets USP — Class II drug recall D-1056-2020
Terminated recall by Lupin Pharmaceuticals Inc., reported 2020-03-18, distributed nationwide. Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
| Recall number | D-1056-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2020-03-09 |
| Classified | 2020-03-24 |
| Reported by FDA | 2020-03-18 |
| Terminated | 2021-05-25 |
| Distributed | Nationwide (US) |
| Quantity | 9,897 cartons |
| Reason classes | specification failure |
| NDC | 68180-0857-11, 68180-0857-13 |
| Lot numbers | L800951 |
| Expiration dates | 2020-07-20 |
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., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.
Reason for recall
Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
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-1056-2020. 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.