Xiromed Recalls Altavera Tablets Due to Generic Name Mislabeling
Xiromed LLC is recalling Altavera tablets because the generic name on the packaging may cause confusion. The FDA classifies this as a Class III recall.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The hazard is limited to labeling confusion.
Plain-English summary
Xiromed LLC is recalling specific lots of Altavera (levonorgestrel and ethinyl estradiol) tablets. The recall is due to mislabeling of the generic name on the packaging component, which may cause confusion. The affected product is a prescription-only medication manufactured in Spain for Xiromed, LLC.
The recall involves 40,064 units of the 3x28 tablet dispensers. The specific lots affected are LF11838A (expiry May 2020), LF12107A, and LF12106A (expiry June 2020). The product was distributed nationwide in the USA.
The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers should check their medication packaging for the affected lot numbers and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- ALTAVERA (LEVONORGESTREL AND ETHINYL ESTRADIOL)
- Brand
- ALTAVERA
- Manufacturer
- Xiromed LLC
- Category
- Drug — Prescription Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lots: LF11838A Expiry May 2020
- LF12107A
- LF12106A
- Expiry June 2020
UPCs (1)
- 0370700116852
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateFDA Recalls Esterified Estrogens Tablets Due to Potential Label Mixup
FDA (Drugs) · 2014-01-22
- LowTeva Recalls Jolessa Tablets Due to Appearance Specification Failures
FDA (Drugs) · 2013-04-17
- LowPrescription Drug Recall: Mimvey Mislabeling by Teva Pharmaceuticals
FDA (Drugs) · 2022-02-09
- LowTeva Recalls Portia Tablets Due to Appearance Specification Failures
FDA (Drugs) · 2013-04-17
- LowAurobindo Recalls Lisinopril Tablets Due to Labeling Error
FDA (Drugs) · 2013-06-05
- LowMylan Recalls Levonorgestrel and Ethinyl Estradiol Tablets Due to Labeling Errors
FDA (Drugs) · 2018-10-24