Xiromed Recalls Altavera Birth Control Due to Labeling Errors
Xiromed LLC recalls Altavera tablets due to mislabeled generic names on packaging. Check your lot numbers and expiry dates for affected units.
Use caution until it’s fixed
Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
Contact the company
What happened, in plain English
Xiromed LLC is recalling Altavera Levonorgestrel and Ethinyl Estradiol Tablets because the generic name on the packaging was mislabeled, which may cause confusion. The recall affects approximately 40,064 units distributed nationwide in the USA. No remedy or return instructions are currently listed in the record. Read more at govinfonow.com/recall/39563-xiromed-recalls-altavera-birth-control-due-to-labeling-errors.
Source Summary by GovInfoNow · govinfonow.com/recall/39563-xiromed-recalls-altavera-birth-control-due-to-labeling-errors · Updated October 11, 2026 · FDA enforcement record: FDA #D-0016-2019
Cite this page
“Xiromed Recalls Altavera Birth Control Due to Labeling Errors.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/39563-xiromed-recalls-altavera-birth-control-due-to-labeling-errors. Based on FDA recall #D-0016-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0016-2019%22&limit=1).
Why it’s dangerous
The hazard is a labeling error where the generic name on the packaging component was mislabeled. This discrepancy may cause patients or healthcare providers to confuse the product with other medications, potentially leading to incorrect usage or treatment decisions.
Who’s affected
Consumers in the USA who purchased Altavera Levonorgestrel and Ethinyl Estradiol Tablets from pharmacies or retailers between the manufacturing date and September 18, 2018. Individuals relying on this specific medication for birth control are most at risk of confusion regarding their dosage.
How to tell if you have this one
Check your medication package for the brand name Altavera and the NDC number 70700-116-85 (or 70700-116-84). Look for lot numbers LF11838A with an expiry of May 2020, or lots LF12107A and LF12106A with an expiry of June 2020. The product is manufactured by Laboratories Leon Farma S.A. in Spain.
- Brand
Xiromed- Category
Drug
What to do — step by step
Check Your Lot Numbers
Verify if your package matches the affected lot numbers (LF11838A, LF12107A, or LF12106A) and expiry dates (May 2020 or June 2020).
Contact Your Pharmacist
Speak with your pharmacist to confirm if you have the recalled product and discuss alternative options.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 6 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0016-2019 (September 18, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0016-2019 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.