Class II · Moderate risk
Estrone 5mg/mL Oil Injection
Lack of sterility assurance.
Is Estrone recalled?
Not under an active recall.
Estrone was recalled 12 times in the past — all now closed. Most recent: Apr 2, 2019.
Most common reason: Cross-contamination (6 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Estrone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Estrone recalls on record
none so far in 2026; 12 on record, newest first
Class II · Moderate risk
Estrone USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Estrone USP
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Estrone
cGMP Deviations: lack of quality assurance at the API manufacturer.
Class II · Moderate risk
Estrone
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class II · Moderate risk
Estrone Micronized
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
Tri-Est 80:10:10 Progesterone
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Triest 80/10/10
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
Triest 80/10/10
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
Triest 70/20/10
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
Estriol 5 Estradiol
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
Estrone active pharmaceutical ingredient packaged in varying grams or kg in bags or drums
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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