# FDA recall D-0428-2024

> **Teva Pharmaceuticals USA, Inc** · Class II · drug recall initiated 2024-03-07.

## 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

## Distribution

USA nationwide.

## Key facts

- **Recall number:** D-0428-2024
- **Recalling firm:** Teva Pharmaceuticals USA, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-03-07
- **Report date:** 2024-04-03
- **Termination date:** 2025-03-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0428-2024

## Citation

> AI Analytics. FDA recall D-0428-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0428-2024. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*