Is Norethindrone recalled?
34 FDA recalls mention Norethindrone. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Norethindrone.
Class II · Moderate risk Ongoing May 27, 2026
Reason Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Class III · Low risk Ongoing Jan 25, 2024
Reason Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class III · Low risk Ongoing Jan 25, 2024
Reason Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class III · Low risk Terminated Jan 7, 2022
Reason Mislabeling
Class III · Low risk Terminated Jan 7, 2022
Reason Mislabeling
Class II · Moderate risk Ongoing Jul 30, 2021
Reason Failed Stability Specifications; out of specification for shear.
Class II · Moderate risk Ongoing Jul 30, 2021
Reason Failed Stability Specifications; out of specification for shear.
Class II · Moderate risk Terminated Mar 15, 2021
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated Jul 21, 2020
Reason Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Class II · Moderate risk Terminated Dec 26, 2019
Reason Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
Class II · Moderate risk Terminated Jul 2, 2019
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 Oct 23, 2018
Reason Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Class II · Moderate risk Terminated Oct 23, 2018
Reason Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Class I · High risk Terminated May 16, 2017
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…
Class II · Moderate risk Terminated Feb 2, 2017
Reason Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
Class III · Low risk Terminated Jan 30, 2017
Reason Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated…
Class III · Low risk Terminated Jan 30, 2017
Reason Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated…
Class III · Low risk Completed Sep 27, 2016
Reason Subpotent Drug; Ethinyl Estradiol
Class III · Low risk Completed Sep 27, 2016
Reason Subpotent Drug; Ethinyl Estradiol
Class III · Low risk Completed Sep 27, 2016
Reason Subpotent Drug; Ethinyl Estradiol
Class III · Low risk Completed Sep 27, 2016
Reason Subpotent Drug; Ethinyl Estradiol
Class III · Low risk Completed Sep 27, 2016
Reason Subpotent Drug; Ethinyl Estradiol
Class II · Moderate risk Terminated Nov 14, 2014
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…
Class III · Low risk Terminated Mar 15, 2013
Reason Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk Terminated Mar 15, 2013
Reason Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing