FDA Drug recall D-0016-2019
Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 mg, Rx only, 3 tablet dispensers x 28 tablets
- FDA Drug
- Class III
- terminated
- Published 2018-10-17
On 2018-10-17 the FDA classified a Class III recall of Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 mg, Rx only, 3 tablet dispensers x 28 tablets by Xiromed, citing labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0016-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-09-18 |
| Published | 2018-10-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Xiromed |
| Distribution | US |
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
Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
Identifiers
| ndc | 70700-116-85 |
|---|---|
| ndc | 70700-116-84 |
| code_info | Lots: LF11838A Expiry May 2020; LF12107A, LF12106A, Expiry June 2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0016-2019%22
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