Class II · Moderate risk
Dutasteride 0.1%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Is Dutasteride recalled?
Not under an active recall.
Dutasteride was recalled 23 times in the past — all now closed. Most recent: Dec 22, 2022.
Most common reason: Sterility / contamination (19 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Dutasteride. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Dutasteride recalls on record
none so far in 2026; 23 on record, newest first
Class II · Moderate risk
Test Cypionate 200mg/Dutasteride 2mg/Ml in Oil Injectable
Lack of assurance of sterility
Class II · Moderate risk
Test Cypionate 200mg/Dutasteride 1mg/Ml in Oil Injectable
Lack of assurance of sterility
Class II · Moderate risk
Test Cypionate 200mg/Dutasteride 0.5mg/Ml in Oil Injectable
Lack of assurance of sterility
Class II · Moderate risk
Test Cypionate 200mg/Anastrozole 2mg/Dutasteride 2mg/Ml in Oil Injectable
Lack of assurance of sterility
Class II · Moderate risk
Test Cypionate 200mg/Anastrozole 2mg/Dutasteride 0.5mg/Ml in Oil Injectable
Lack of assurance of sterility
Class II · Moderate risk
Test Cypionate 200mg/Anastrozole 1mg/Dutasteride 2mg/Ml in Oil Injectable
Lack of assurance of sterility
Class II · Moderate risk
Test Cypionate 200mg/Anastrozole 1mg/Dutasteride 1mg/Ml in Oil Injectable
Lack of assurance of sterility
Class II · Moderate risk
Test Cypionate 200mg/Anastrozole 1mg/Dutasteride 1.5mg/Ml in Oil Injectable
Lack of assurance of sterility
Class II · Moderate risk
Test Cypionate 200mg/Anastrozole 1mg/Dutasteride 0.5mg/Ml in Oil Injectable
Lack of assurance of sterility
Class II · Moderate risk
Test Cypionate 200mg/Anastrozole 1.5mg/Dutasteride 2mg/Ml in Oil Injectable
Lack of assurance of sterility
Class II · Moderate risk
Test Cypionate 200mg/Anastrozole 1.5mg/Dutasteride 1.5mg/Ml in Oil Injectable
Lack of assurance of sterility
Class II · Moderate risk
Test Cypionate 200mg/Anastrozole 0.75mg/Dutasteride 1mg/Ml in Oil Injectable
Lack of assurance of sterility
Class II · Moderate risk
Test Cypionate 200mg/Anastrozole 0.5mg/Dutasteride 1mg/Ml in Oil Injectable
Lack of assurance of sterility
Class II · Moderate risk
Test Cypionate 200mg/Anastrozole 0.5mg/Dutasteride 1mg/Ml #2 Injectable
Lack of assurance of sterility
Class II · Moderate risk
Test Cypionate 200mg/Anastrozole 0.5mg/Dutasteride 1.5mg/Ml in Oil Injectable
Lack of assurance of sterility
Class II · Moderate risk
Test Cypionate 200mg/Anastrozole 0.5mg/Dutasteride 0.75mg/Ml in Oil Injectable
Lack of assurance of sterility
Class II · Moderate risk
Test Cypionate 200mg/Anastrozole 0.5mg/Dutasteride 0.5mg/Ml in Oil Injectable
Lack of assurance of sterility
Class II · Moderate risk
Test Cypionate 200mg/Anastrozole 0.25mg/Dutasteride 1mg/Ml in Oil Injectable
Lack of assurance of sterility
Class II · Moderate risk
Dutasteride Capsules
Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
Class II · Moderate risk
Dutasteride and Tamsulosin HCl Capsules
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Class II · Moderate risk
Dutasteride
Labeling: Label Mixup: DUTASTERIDE, Capsule, 0.5 mg may have potentially been mislabeled as one of the following drugs: PHENOL, LOZENGE, 29 mg, NDC 00068021918, Pedigree: AD49582_13, EXP: 5/16/2014; REPAGLINIDE, Tablet, 2 mg, NDC 00169008481, Pedigree: AD70639_13, EXP: 5/29/2014; CHOLECALCIFEROL, Capsule, 5000 units, NDC 00904598660, Pedigree: AD52993_22, EXP: 5/20/2014.
Class II · Moderate risk
Dutasteride
Labeling: Label Mixup: DUTASTERIDE, Capsule, 0.5 mg may have potentially been mislabeled as one of the following drugs: DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD65457_19, EXP: 5/24/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD56924_1, EXP: 5/21/2014; PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: W003257, EXP: 6/17/2014.
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