Class II · Moderate risk
MY CHOICE LEVONORGESTREL TABLET distributed to specific Family…
CGMP Deviations: product held outside appropriate storage temperature conditions.
Is Levonorgestrel recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Levonorgestrel (23 total). Check the affected lots below.
Most common reason: Labeling / mix-up (6 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Levonorgestrel. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Levonorgestrel recalls on record
none so far in 2026; 23 on record, newest first
Class II · Moderate risk
Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP)
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Levonorgestrel and Ethinyl Estradiol Tablets USP
Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
Class II · Moderate risk
Fayosim (levonorgestrel and ethinyl estradiol)
Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.
Class III · Low risk
Altavera Levonorgestrel and Ethinyl Estradiol Tablets
Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
Class III · Low risk
Levonorgestrel and Ethinyl Estradiol Tablets
Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Class II · Moderate risk
My Way (levonorgestrel)
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Class II · Moderate risk
My Way (Levonorgestrel)
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Class II · Moderate risk
Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg)
Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
Class II · Moderate risk
Option 2
Defective Container: Carton is missing the tablet blister strip and tablet.
Class II · Moderate risk
Levonorgestrel
CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.
Class II · Moderate risk
Levonorgestrel Non-Micronized
cGMP Deviations; lack of quality assurance.
Class III · Low risk
Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP)
Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.
Class II · Moderate risk
Next Choice" One Dose Emergency Contraceptive
Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.
Class III · Low risk
Introvale (levonorgestrel and ethinyl estradiol)
Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily being recalled due to inactive placebo tablets incorrectly placed in Week 9, and active tablets placed in Week 13 on the blister card
Class III · Low risk
Jolessa (levonorgestrel/ethinyl estradiol tablets, USP)
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk
Lessina (Levonorgestrel and ethinyl estradiol tablets, USP)
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk
Camrese (Levonorgestrel/Ethinyl Estradiol Tablets)
Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Class III · Low risk
Seasonale (Levonorgestrel/Ethinyl Estradiol Tablets)
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Class III · Low risk
Jolessa (levonorgestrel/ethinyl estradiol)
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
Class III · Low risk
Portia (levonorgestrel and ethinyl estradiol)
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
Class II · Moderate risk
Lutera (levonorgestrel and ethinyl estradiol)
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
Class III · Low risk
Jolessa (levonorgestrel/ethinyl estradiol tablets, USP)
Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets.
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