Fayosim — Class II drug recall D-1057-2019
Terminated recall by Lupin Pharmaceuticals Inc., reported 2019-04-03, distributed nationwide. Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test
| Recall number | D-1057-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2019-03-22 |
| Classified | 2019-03-25 |
| Reported by FDA | 2019-04-03 |
| Terminated | 2020-07-01 |
| Distributed | Nationwide (US) |
| Quantity | 12,464 cartons |
| Reason classes | specification failure |
| NDC | 68180-0860-11, 68180-0860-12 |
| Lot numbers | L800016, L800721 |
| Expiration dates | 2019-12, 2020-05 |
Product
Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets USP, (0.01 mg), packaged in 1 Extended-Cycle Wallet of 91 Tablets packed in a pouch(NDC 68180-860-11); one pouch per carton (NDC 68180-860-12), Rx only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.
Reason for recall
Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.
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-1057-2019. 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.