Tri-Lo-Marzia — Class III drug recall D-0790-2020
Terminated recall by Lupin Pharmaceuticals Inc., reported 2020-01-22, distributed nationwide. CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity tes
| Recall number | D-0790-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2020-01-10 |
| Classified | 2020-01-17 |
| Reported by FDA | 2020-01-22 |
| Terminated | 2021-06-03 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp, specification failure |
| NDC | 68180-0837-11, 68180-0837-13 |
| Lot numbers | L800498 |
| Expiration dates | 2020-02-20 |
Product
Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, Distributed by Lupin Pharmaceuticals, Inc, Baltimore MD 21202, Manufactured by: Lupin Limited, Pithampur, (M.P.)- 454775, India. NDC 68180-837-13 (3x28 carton ) NDC 68180-837-11 (28 tablet wallet)
Reason for recall
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
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-0790-2020. 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.