Finasteride recalls

The FDA has published 6 recalls involving Finasteride since 2014. The latest was reported on 12 Apr 2023. Most were for manufacturing (cgmp) deviations. Accord Healthcare has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls6since 2014

Last 12 months0reported

Class I00% of total

Ongoing1latest 12 Apr 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 5 83%Class III 1 17%

Why finasteride is recalled

Companies

By year

2023467%
2017117%
2014117%

Ongoing finasteride recalls

1 active

Reported	Class	Recall	Company	Reason	Where
12 Apr 2023Drug	CLASS II	Finasteride Tablets, USP, 5 mg recalled by Preferred Pharmaceuticals	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

All finasteride recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
12 Apr 2023Drug	CLASS II	Finasteride Tablets, USP, 5 mg recalled by Preferred Pharmaceuticals	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
8 Mar 2023Drug	CLASS II	Finasteride Tablets USP, 1 mg recalled by Accord HealthcareFinasteride	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Finasteride Tablets USP, 5 mg recalled by Accord HealthcareFinasteride	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Finasteride Tablets USP 1 mg, Keeps recalled by Accord Healthcare	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Feb 2017Drug	CLASS III	Finasteride Tablets, USP 5 mg recalled by Hetero Drugs Ltd. - Unit 1Finasteride	Hetero Drugs Ltd. - Unit 1	Other	NJ
22 Jan 2014Drug	CLASS II	Finasteride Tablet, 5 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Finasteride?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.