FDA Drug Recalls
436 recalls, newest first
Class II · Moderate risk Completed May 22, 2023
Reason Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of…
Class II · Moderate risk Completed May 12, 2023
Reason Mislabeling: preservative free product labeled as preserved.
Class II · Moderate risk Completed Apr 26, 2023
Reason Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Class II · Moderate risk Completed Apr 7, 2023
Reason CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Class II · Moderate risk Completed Mar 15, 2023
Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Class II · Moderate risk Completed Mar 15, 2023
Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Class II · Moderate risk Completed Mar 1, 2023
Reason Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a…
Class II · Moderate risk Completed Feb 10, 2023
Reason Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the…
Class II · Moderate risk Completed Feb 10, 2023
Reason Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the…
Class II · Moderate risk Completed Dec 29, 2022
Reason Lack of assurance of sterility: Bags have the potential to leak.
Class II · Moderate risk Completed Dec 22, 2022
Reason Failed impurities/degradation specifications: Out of specification for unknown impurities.
Class II · Moderate risk Completed Dec 9, 2022
Reason CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.
Class II · Moderate risk Completed Dec 2, 2022
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk Completed Dec 2, 2022
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk Completed Dec 2, 2022
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk Completed Dec 2, 2022
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk Completed Dec 2, 2022
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk Completed Dec 2, 2022
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk Completed Dec 2, 2022
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk Completed Oct 5, 2022
Reason CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Class II · Moderate risk Completed Sep 30, 2022
Reason Out of specification for related substances (impurities).
Class II · Moderate risk Completed Sep 26, 2022
Reason Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Class III · Low risk Completed Sep 14, 2022
Reason Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Class II · Moderate risk Completed Sep 12, 2022
Reason CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Class II · Moderate risk Completed Aug 26, 2022
Reason Lack of Assurance of Sterility