Teva Recalls Jolessa Tablets Due to Appearance Specification Failures
Teva Pharmaceuticals is recalling specific lots of Jolessa tablets because they failed appearance specifications. The recall is nationwide.
What this means for you
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, and the source text identifies the issue as an appearance specification failure, which is a cosmetic defect unlikely to cause adverse health consequences.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling 71,893 dispensers of Jolessa (levonorgestrel/ethinyl estradiol) tablets, 0.15 mg/0.03 mg. The affected product is packaged in 91-count extended-cycle tablet dispensers, with three dispensers per carton. The recall is being conducted due to an out-of-specification result for appearance.
The recall affects lots 33803603A and 33803604A (expiration 11/13) and lots 33803996A and 33803997A (expiration 03/14). The product was distributed nationwide. The tablets are manufactured by Barr Laboratories, Inc., and marketed by Teva Pharmaceuticals USA, Inc.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative contraceptive options if necessary.
The recalled product
- Product
- JOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL)
- Brand
- JOLESSA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Category
- Drug — Oral Contraceptive
- Hazard
- Affected units
- 71,893
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 (6)
- Lot #: 33803603A
- 33803604A
- Exp 11/13
- 33803996A
- and 33803997A
- Exp 03/14
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Teva Pharmaceuticals USA, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same brand · JOLESSA
- LowTeva Recalls Jolessa Birth Control Tablets Due to Impurity Detection
FDA (Drugs) · 2013-07-17
- LowTeva Recalls Jolessa Contraceptive Tablets Due to Missing Placebo Tablets
FDA (Drugs) · 2012-06-27
Same manufacturer · Teva Pharmaceuticals USA, Inc.
See all →- SevereOctreotide Acetate Injectable Suspension Recalled Due to Sterility Assurance
FDA (Drugs) · 2026-05-13
- ModerateClaravis isotretinoin 10 mg capsules recalled for out-of-specification impurity
FDA (Drugs) · 2026-04-29
- ModerateTeva clonidine 0.2 mg patches recalled over unapproved raw material use
FDA (Drugs) · 2026-04-15
- HighTeva isotretinoin 30 mg capsules recalled as superpotent and subpotent
FDA (Drugs) · 2026-04-15
- HighTeva isotretinoin 40 mg capsules recalled as superpotent and subpotent
FDA (Drugs) · 2026-04-15
Same hazard · cosmetic defect
See all →- LowNilotinib capsules recalled after failing appearance tests at six months
FDA (Drugs) · 2026-03-11
- LowNilotinib 200 mg capsules recalled after failing appearance tests
FDA (Drugs) · 2026-03-11
- LowTrazodone tablets recalled after complaints of a dent on the tablet surface
FDA (Drugs) · 2026-01-07
- LowAneurysm clips recalled due to incorrect paddle coloring
FDA (Devices) · 2024-03-20
- ModerateSteris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration
FDA (Devices) · 2021-01-13