Altavera Levonorgestrel and Ethinyl Estradiol Tablets — Class III drug recall D-0016-2019
Terminated recall by Xiromed LLC, reported 2018-10-17, distributed nationwide. Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that m
| Recall number | D-0016-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Xiromed LLC, Florham Park, NJ, United States |
| Recall initiated | 2018-09-18 |
| Classified | 2018-10-11 |
| Reported by FDA | 2018-10-17 |
| Terminated | 2019-03-26 |
| Distributed | Nationwide (US) |
| Quantity | 40,064 |
| Reason classes | labeling |
| NDC | 70700-0116, 70700-0116-84, 70700-0116-85 |
| Lot numbers | LF11838A, LF12106A, LF12107A |
| Expiration dates | 2020-05-20, 2020-06-20 |
Product
Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 mg, Rx only, 3 tablet dispensers x 28 tablets. Manufactured by Laboratories Leon Farma S.A., Spain, for Xiromed, LLC., Florham Park, NJ 07932. Product of Spain NDC 70700-116-85 (I unit x 28 tablets 70700-116-84)
Reason for recall
Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
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-0016-2019. 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.