Is Hydrochlorothiazide recalled?
129 FDA recalls mention Hydrochlorothiazide. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Hydrochlorothiazide.
Class II · Moderate risk Terminated Mar 21, 2022
Reason CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk Terminated Mar 21, 2022
Reason CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
Class II · Moderate risk Terminated Jan 26, 2022
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated Jan 26, 2022
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class III · Low risk Terminated Dec 1, 2021
Reason Superpotent; Hydrochlorothiazide
Class II · Moderate risk Terminated Oct 12, 2021
Reason CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk Terminated Oct 12, 2021
Reason CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk Terminated Mar 15, 2021
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated Mar 15, 2021
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk Terminated Oct 2, 2020
Reason Out-of-specification organic impurity results obtained during routine stability testing.
Class II · Moderate risk Terminated Jul 27, 2020
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk Terminated Jul 27, 2020
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk Terminated Jul 27, 2020
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk Ongoing Sep 19, 2019
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
Class II · Moderate risk Ongoing Sep 19, 2019
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
Class II · Moderate risk Terminated Jul 19, 2019
Reason Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.
Class II · Moderate risk Terminated Jul 17, 2019
Reason Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed…
Class II · Moderate risk Terminated Jun 20, 2019
Reason CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to…
Class II · Moderate risk Terminated Jun 20, 2019
Reason CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to…
Class II · Moderate risk Terminated Jun 20, 2019
Reason CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to…
Class II · Moderate risk Ongoing Apr 18, 2019
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
Class II · Moderate risk Ongoing Apr 18, 2019
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
Class II · Moderate risk Ongoing Apr 18, 2019
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
Class II · Moderate risk Terminated Mar 5, 2019
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Class II · Moderate risk Terminated Mar 5, 2019
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified