Progesterone Injection USP
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Yes — there is an active recall. 4 ongoing FDA recalls mention Progesterone (103 total). Check the affected lots below.
Most common reason: cGMP deviation (31 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Progesterone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Presence of Foreign Substance; Broken metal piece found embedded in tablet.
cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Lack of assurance of sterility
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Non-Sterility
Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Control
Lack of Processing Control
Lack of Processing Control
Lack of Processing Control
Lack of Processing Control
Lack of Processing Control
Lack of Processing Control
Lack of Processing Control
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