CLASS II Drug recall · Reported 8 Mar 2023 · FDA Enforcement Report

Finasteride Tablets USP 1 mg, Keeps recalled by Accord Healthcare

Accord Healthcare is recalling Finasteride Tablets USP 1 mg, Keeps, distributed in Puerto Rico. The recall was initiated on 7 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatches: P2005583, P2005584, P2005585, P2005527, P2005528, P2005586, Exp. Date 9/30/2023; P2005980, Exp. Date 10/31/2023; P2100396, P2100264, P2100263, Exp. Date 12/31/2023; P2101583, P2101711, P2101708, P2101584, Exp. Date 2/29/2024; P2102852, P2102851, P2102853, P2102854, P2102855, Exp. Date 4/30/2024; P2103993, P2103998, P2103997, P2103999, P2104205, P2104206, P2105631, P2105632, P2105546, P2105547, P2105548 Exp. Date 8/31/2024;

Quantity recalled1,440,652 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0391-2023
FDA event ID: 91657
Recalling firm: Accord Healthcare, Durham, NC
Classification: Class II
Status: Terminated
Recall initiated: 7 Feb 2023
FDA classified: 2 Mar 2023
Reported: 8 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Drug class: Bladder & Prostate Medication

Timeline

7 Feb 2023	Recall initiated by company
2 Mar 2023	Classified by FDA	+23 days
8 Mar 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP Deviations: recalling drug products following an FDA inspection.

Product as listed by the FDA

Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty Madison, Inc. New York, NY 10016 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 71713-096-90 UPC 3 71713 09690 2

Where it was distributed

United States including Puerto Rico and Canada

Puerto Rico

Questions about this recall

Is Finasteride Tablets USP 1 mg, Keeps recalled?

Yes. Accord Healthcare recalled Finasteride Tablets USP 1 mg, Keeps on 7 Feb 2023. The recall is Class II and its status is Terminated. Recall number D-0391-2023.

Why was it recalled?

CGMP Deviations: recalling drug products following an FDA inspection.

Which lots are affected?

Batches: P2005583, P2005584, P2005585, P2005527, P2005528, P2005586, Exp. Date 9/30/2023; P2005980, Exp. Date 10/31/2023; P2100396, P2100264, P2100263, Exp. Date 12/31/2023; P2101583, P2101711, P2101708, P2101584, Exp. Date 2/29/2024; P2102852, P2102851, P2102853, P2102854, P2102855, Exp. Date 4/30/2024; P2103993, P2103998, P2103997, P2103999, P2104205, P2104206, P2105631, P2105632, P2105546, P2105547, P2105548 Exp. Date 8/31/2024;

Where was it sold?

United States including Puerto Rico and Canada

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Other Finasteride recalls

All 6

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 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