CLASS III Drug recall · Reported 17 Oct 2018 · FDA Enforcement Report
Altavera Levonorgestrel and Ethinyl Estradiol Tablets recalled
Xiromed is recalling Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 mg, distributed nationwide in the US. The recall was initiated on 18 Sep 2018 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0016-2019
- FDA event ID
- 81044
- Recalling firm
- Xiromed, Florham Park, NJ
- Brand
- Altavera
- Manufacturer
- Xiromed, LLC.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Sep 2018
- FDA classified
- 11 Oct 2018
- Reported
- 17 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Hormones & Birth Control
Timeline
| 18 Sep 2018 | Recall initiated by company | |
| 11 Oct 2018 | Classified by FDA | +23 days |
| 17 Oct 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
Product as listed by the FDA
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)
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
Which lots are affected?
Lots: LF11838A Expiry May 2020; LF12107A, LF12106A, Expiry June 2020
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Levonorgestrel recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levonorgestrel and Ethinyl Estradiol Tablets recalled | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg recalled | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Option 2, Levonorgestrel Tablet, 1.5 mg, Emergency Contraceptive recalledOption 2 | L. Perrigo | Other | Nationwide |
| Drug | CLASS III | Lessina(R) (Levonorgestrel and ethinyl estradiol tablets recalledLessina | Teva Pharmaceuticals USA | Benzene | Nationwide |
| Drug | CLASS III | Portia (levonorgestrel and ethinyl estradiol) Tablets recalledPortia | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |