Amethyst — Class II drug recall D-0125-2018
Terminated recall by Teva Pharmaceuticals USA, reported 2017-12-27, distributed nationwide. Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package ins
| Recall number | D-0125-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2017-11-20 |
| Classified | 2017-12-20 |
| Reported by FDA | 2017-12-27 |
| Terminated | 2018-06-21 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Lot numbers | 544637A |
Product
Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil unit), Rx only, Manufactured by: Warner Chilcott Company, LLC Fajardo, Puerto Rico 00738: Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA, NDC-52544-295-28
Reason for recall
Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
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-0125-2018. 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.