FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing Oct 7, 2025
Reason Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150…
Class II · Moderate risk Ongoing Oct 6, 2025
Reason CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk Ongoing Oct 6, 2025
Reason CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk Ongoing Oct 6, 2025
Reason CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk Ongoing Oct 6, 2025
Reason CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk Ongoing Oct 6, 2025
Reason CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk Ongoing Oct 6, 2025
Reason CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Class II · Moderate risk Ongoing Oct 6, 2025
Reason Discoloration
Class II · Moderate risk Ongoing Oct 3, 2025
Reason Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Class II · Moderate risk Ongoing Oct 1, 2025
Reason Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
Class II · Moderate risk Ongoing Oct 1, 2025
Reason Presence of Particulate Matter: Particulate matter identified as glass
Class II · Moderate risk Ongoing Sep 29, 2025
Reason Subpotent Drug
Class II · Moderate risk Ongoing Sep 29, 2025
Reason Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Class II · Moderate risk Ongoing Sep 29, 2025
Reason cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand…
Class II · Moderate risk Ongoing Sep 29, 2025
Reason cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand…
Class II · Moderate risk Ongoing Sep 26, 2025
Reason Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Class II · Moderate risk Ongoing Sep 25, 2025
Reason cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
Class II · Moderate risk Ongoing Sep 24, 2025
Reason Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Class II · Moderate risk Ongoing Sep 24, 2025
Reason Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Class II · Moderate risk Ongoing Sep 23, 2025
Reason CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Class II · Moderate risk Ongoing Sep 23, 2025
Reason Product Mix-up
Class II · Moderate risk Terminated Sep 22, 2025
Reason Lack of assurance of sterility.
Class II · Moderate risk Ongoing Sep 19, 2025
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing Sep 19, 2025
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing Sep 19, 2025
Reason Failed Dissolution Specifications