Class II · Moderate risk
Estriol 1mg/gm
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Is Estriol recalled?
Not under an active recall.
Estriol was recalled 90 times in the past — all now closed. Most recent: Jun 10, 2022.
Most common reason: Cross-contamination (65 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Estriol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Estriol recalls on record
none so far in 2026; 90 on record, newest first
Class II · Moderate risk
Estriol 1mg/gm
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Estriol USP41 Micro 25 Grams
cGMP Deviations
Class II · Moderate risk
Estriol 8 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Estriol 6 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Estriol USP Micronized 5 G
Failed impurities/ degradation specifications: Out of specification for organic impurities.
Class II · Moderate risk
Estriol/Testosterone Vaginal 0.1/0.1% Cream 30 gm jar
Lack of Processing Control
Class II · Moderate risk
Estriol 5 mg Suppository 36 each box
Lack of Processing Control
Class II · Moderate risk
Estriol Vaginal Cream
Lack of Processing Control
Class II · Moderate risk
Class II · Moderate risk
Estriol
Subpotent Drug: Supplier indicated assay results did not meet specifications.
Class II · Moderate risk
Estriol
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Class II · Moderate risk
Estriol
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Class II · Moderate risk
Estriol
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Class II · Moderate risk
Estriol
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Estriol USP
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
Estriol 0.1%
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Bi-Est (Estriol/Estradiol)
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Estriol
cGMP Deviations: lack of quality assurance at the API manufacturer.
Class II · Moderate risk
Estriol
cGMP Deviations: lack of quality assurance at the API manufacturer.
Class II · Moderate risk
Estriol
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class II · Moderate risk
Estriol Micronized
cGMP Deviations; lack of quality assurance.
Class II · Moderate risk
All estriol Products
Lack of Processing Controls
Class II · Moderate risk
ESTRIOL Gels
Penicillin Cross Contamination: potentially contaminated with penicillin
Class II · Moderate risk
ESTRIOL Creams
Penicillin Cross Contamination: potentially contaminated with penicillin
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