Tri-Lo-Sprintec — Class II drug recall D-0428-2024
Terminated recall by Teva Pharmaceuticals USA, Inc, reported 2024-04-03, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0428-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Inc, Parsippany, NJ, United States |
| Recall initiated | 2024-03-07 |
| Classified | 2024-03-28 |
| Reported by FDA | 2024-04-03 |
| Terminated | 2025-03-06 |
| Distributed | Nationwide (US) |
| Quantity | 92,676 cartons |
| Reason classes | specification failure |
| NDC | 00093-2140, 00093-2140-28, 00093-2140-62 |
| Lot numbers | 100038111, 100039678, 100042277 |
| Expiration dates | 2024-07-31 |
Product
Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Blister Cards, 28 Tablets Each, Rx only, Teva Pharmaceuticals USA, INC, North Wales, PA 19454, NDC 0093-2140-62
Reason for recall
Failed Dissolution Specifications
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-0428-2024. 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.