Actavis Recalls Lutera Birth Control Due to Outdated Package Inserts
Actavis Inc is recalling Lutera birth control tablets because the packs were distributed with out-dated package inserts.
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 recall is classified as FDA Class III, which indicates a violation of labeling or FDA regulations that is not likely to cause adverse health consequences. The hazard is limited to outdated documentation.
Plain-English summary
Actavis Inc is recalling specific lots of Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP). The product is a 28-day regimen birth control medication manufactured for Watson Pharm, Inc. and manufactured by Patheon, Inc.
The recall was initiated because the birth control packs were distributed with out-dated package inserts. This is a labeling issue where the provided instructions may not reflect the most current information.
Consumers who have this product should check their packaging for the affected lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, consumers should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen, 6 Tablet Dispensers per box, 28 Tablets Each, Rx Only, Manufactured for: Watson Pharm, Inc., a subsidiary of Watson Pharmaceutical, Inc., Corona, CA 92880, Manufactured by: Patheon, Inc.…
- Manufacturer
- Actavis Inc
- Category
- Drug — Oral Contraceptive
- Hazard
- Affected units
- 511,283
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 (20)
- Lot #s: KPPY
- Exp 06/15
- NBXD
- NBXF
- Exp 10/16
- NBXG
- Exp 09/15
- NKZS
- Exp 11/15
- NMPT
- NNXB
- NNWG
- Exp 01/16
- NMPV
- NVWN
- NVWP
- Exp 02/16
- NMTP
- NNXC
- Exp 03/16
Distribution
Related recalls
Same manufacturer · Actavis Inc
See all →- ModerateActavis Recalls Levofloxacin Ophthalmic Solution Due to Impurity Failure
FDA (Drugs) · 2017-03-15
- ModerateActavis Recalls Glipizide Extended-Release Tablets Due to Dissolution Failure
FDA (Drugs) · 2017-02-22
- LowActavis Recalls Albuterol Sulfate Inhalation Solution Due to Impurities
FDA (Drugs) · 2017-02-01
- LowActavis Recalls Acetasol HC Otic Solution Due to Impurity Failure
FDA (Drugs) · 2016-08-31
- LowActavis Recalls Hydrocortisone and Acetic Acid Otic Solution Due to Impurities
FDA (Drugs) · 2016-08-31
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
- ModerateWatson Recalls Lutera Tablets Due to Potential Hydrochlorothiazide Contamination
FDA (Drugs) · 2012-10-31
- ModerateLupin Recalls Levonorgestrel and Ethinyl Estradiol Tablets for Content Uniformity
FDA (Drugs) · 2020-03-18
- LowLupin Recalls Escitalopram Tablets Due to Incorrect or Missing Lot and Expiration Dates
FDA (Drugs) · 2016-09-28
- LowActavis Recalls Ramipril Capsules Due to Incorrect Expiration Date Labeling
FDA (Drugs) · 2016-11-09
- ModerateTeva Recalls Amethyst Oral Contraceptive Tablets Due to Incorrect Labeling
FDA (Drugs) · 2017-12-27
- LowWatson Recalls Caziant Tablets Due to Out-of-Specification Impurities
FDA (Drugs) · 2012-12-26