Class II · Moderate risk
Alyacen 7/7/7
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Is Norethindrone recalled?
Yes — there is an active recall. 5 ongoing FDA recalls mention Norethindrone (34 total). Check the affected lots below.
Most common reason: Chemical / undeclared (9 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Norethindrone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Norethindrone recalls in 2026
1 initiated in 2026, 34 in total — newest first
Class III · Low risk
Nortrel 7/7/7
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class III · Low risk
Nortrel (norethindrone and ethinyl estradiol tablets USP)
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class III · Low risk
Class III · Low risk
Class II · Moderate risk
Combipatch
Failed Stability Specifications; out of specification for shear.
Class II · Moderate risk
Combipatch
Failed Stability Specifications; out of specification for shear.
Class II · Moderate risk
Balziva 28 Day
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Mibelas 24 Fe
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Class II · Moderate risk
Blisovi Fe 1.5/30
Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
Class II · Moderate risk
Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets
Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
Class II · Moderate risk
Ortho-Novum 7/7/7
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Class II · Moderate risk
Ortho-Novum 1/35
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Class I · High risk
Mibelas 24 Fe
Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.
Class II · Moderate risk
Mimvey Lo (estradiol and norethindrone acetate tablets USP)
Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
Class III · Low risk
Norethindrone Acetate and Ethinyl Estradiol Tablets
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Class III · Low risk
Tarina Fe 1/20
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Class III · Low risk
Gildess 24 FE 1.5/30
Subpotent Drug; Ethinyl Estradiol
Class III · Low risk
Gildess FE 1.5/30
Subpotent Drug; Ethinyl Estradiol
Class III · Low risk
Gildess FE 1/20
Subpotent Drug; Ethinyl Estradiol
Class III · Low risk
Gildess 1/20
Subpotent Drug; Ethinyl Estradiol
Class III · Low risk
Gildess 1.5/30
Subpotent Drug; Ethinyl Estradiol
Class II · Moderate risk
Norethindrone Acetate active pharmaceutical ingredient packaged…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class III · Low risk
Camila (norethindrone tablets, USP)
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk
Errin (norethindrone tablets, USP)
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
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