Class II · Moderate risk Ongoing
Alyacen 7/7/7
Reason 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.
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.
Class III · Low risk Ongoing
Nortrel 7/7/7
Reason Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class III · Low risk Ongoing
Nortrel
Reason Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class III · Low risk Terminated
Mimvey
Reason Mislabeling
Class III · Low risk Terminated
Mimvey
Reason Mislabeling
Class II · Moderate risk Ongoing
Combipatch
Reason Failed Stability Specifications; out of specification for shear.
Class II · Moderate risk Ongoing
Combipatch
Reason Failed Stability Specifications; out of specification for shear.
Class II · Moderate risk Terminated
Balziva 28 Day
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Mibelas 24 Fe
Reason Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Class II · Moderate risk Terminated
Blisovi Fe 1.5/30
Reason Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
Class II · Moderate risk Terminated
Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets
Reason Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
Class II · Moderate risk Terminated
Ortho-Novum 7/7/7
Reason Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Class II · Moderate risk Terminated
Ortho-Novum 1/35
Reason Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Class I · High risk Terminated
Mibelas 24 Fe
Reason 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 Terminated
Mimvey Lo
Reason Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
Class III · Low risk Terminated
Norethindrone Acetate and Ethinyl Estradiol Tablets
Reason 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 Terminated
Tarina Fe 1/20
Reason 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 Completed
Gildess 24 FE 1.5/30
Reason Subpotent Drug; Ethinyl Estradiol
Class III · Low risk Completed
Gildess FE 1.5/30
Reason Subpotent Drug; Ethinyl Estradiol
Class III · Low risk Completed
Gildess FE 1/20
Reason Subpotent Drug; Ethinyl Estradiol
Class III · Low risk Completed
Gildess 1/20
Reason Subpotent Drug; Ethinyl Estradiol
Class III · Low risk Completed
Gildess 1.5/30
Reason Subpotent Drug; Ethinyl Estradiol
Class II · Moderate risk Terminated
Norethindrone Acetate active pharmaceutical ingredient packaged…
Reason 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 Terminated
Camila
Reason Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk Terminated
Errin
Reason Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
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