Bladder & Prostate Medication recalls

The FDA has published 42 recalls involving bladder & prostate medication since 2014. The latest was reported on 12 Aug 2026. Most were for potency & assay. Aidapak Services 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 recalls42since 2014

Last 12 months1reported

Class I12% of total

Ongoing5latest 12 Aug 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 1 3 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 1Aug 0 0

Severity split

Class I 1 2%Class II 35 83%Class III 6 14%

Why bladder & prostate medication is recalled

Companies

Brands

By year

202612%
2025410%
2023921%
202112%
2020717%
2019410%
201812%
201725%
201537%
20141024%

Ongoing bladder & prostate medication recalls

5 active

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Drug	CLASS II	Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
16 Apr 2025Drug	CLASS II	Solifenacin Succinate Tablets 10MG, a. bottle recalledSolifenacin Succinate	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Solifenacin Succinate Tablets 5mg, a.) bottle recalledSolifenacin Succinate	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
19 Mar 2025Drug	CLASS II	Finasteride recalled by Aspen Biopharma Labs Pvt	Aspen Biopharma Labs	Manufacturing (CGMP) Deviations	FL
12 Apr 2023Drug	CLASS II	Finasteride Tablets, USP, 5 mg recalled by Preferred Pharmaceuticals	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

All bladder & prostate medication recalls, newest first

42 total

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Drug	CLASS II	Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
16 Apr 2025Drug	CLASS II	Solifenacin Succinate Tablets 10MG, a. bottle recalledSolifenacin Succinate	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Solifenacin Succinate Tablets 5mg, a.) bottle recalledSolifenacin Succinate	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
9 Apr 2025Drug	CLASS III	Tolterodine Tartrate Extended-Release Capsules, 2 mg Dose recalled	The Harvard Drug Group	Potency & Assay	Nationwide
19 Mar 2025Drug	CLASS II	Finasteride recalled by Aspen Biopharma Labs Pvt	Aspen Biopharma Labs	Manufacturing (CGMP) Deviations	FL
15 Nov 2023Drug	CLASS II	Oxybutynin Chloride Extended-Release Tablet USP, 10 mg recalledOxybutynin	Zydus Pharmaceuticals	Potency & Assay	Nationwide
15 Nov 2023Drug	CLASS II	Oxybutynin Chloride Extended-Release Tablet USP, 15 mg recalledOxybutynin	Zydus Pharmaceuticals	Potency & Assay	Nationwide
15 Nov 2023Drug	CLASS II	Oxybutynin Chloride Extended-Release Tablet USP, 5 mg recalledOxybutynin	Zydus Pharmaceuticals	Potency & Assay	Nationwide
11 Oct 2023Drug	CLASS II	Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) recalledOxybutynin	Zydus Pharmaceuticals	Potency & Assay	Nationwide
12 Apr 2023Drug	CLASS II	Finasteride Tablets, USP, 5 mg recalled by Preferred Pharmaceuticals	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
5 Apr 2023Drug	CLASS II	Finasteride recalled by Direct Rx	Direct Rx	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 Healthcare	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
21 Jul 2021Drug	CLASS II	Solifenacin Succinate Tablets, 10 mg recalled by CIPLA	Cipla	Manufacturing (CGMP) Deviations	Nationwide
5 Aug 2020Drug	CLASS II	Formula 82F (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone recalled	MasterPharm	Other	Nationwide
5 Aug 2020Drug	CLASS II	Finasteride Plus 1.25mg Capsule per, MasterPharm recalled	MasterPharm	Other	Nationwide
20 May 2020Drug	CLASS I	Finasteride Plus 1., a), b), Compounded Product recalled by MasterPharm	MasterPharm	Other	Nationwide
25 Mar 2020Drug	CLASS II	Solifenacin Succinate Tablets, 5mg recalled	Breckenridge Pharmaceutical	Manufacturing (CGMP) Deviations	Nationwide
25 Mar 2020Drug	CLASS II	Solifenacin Succinate Tablets, 10 mg recalled	Breckenridge Pharmaceutical	Manufacturing (CGMP) Deviations	Nationwide
5 Feb 2020Drug	CLASS II	Finasteride/Biotin 1 mg/50 mcg recalled by MPRX	Mprx	Other	TX
22 Jan 2020Drug	CLASS II	Dutasteride Capsules, 0.5 mg Dose recalled by AVKARE	Avkare	Potency & Assay	Nationwide
21 Aug 2019Drug	CLASS II	Tamsulosin Hydrochloride Capsules, USP 0.4 mg recalledTamsulosin Hydrochloride	Macleods Pharma Usa	Potency & Assay	Nationwide
20 Mar 2019Drug	CLASS III	Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg recalledOxybutynin Chloride	Lannett	Potency & Assay	Nationwide
20 Mar 2019Drug	CLASS III	Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) recalledOxybutynin Chloride	Avkare	Potency & Assay	Nationwide
13 Mar 2019Drug	CLASS II	Tamsulosin Hydrochloride Capsules, USP, 0.4 mg recalledTamsulosin Hydrochloride	Ascend Laboratories	Potency & Assay	Nationwide
26 Dec 2018Drug	CLASS II	Oxybutynin Chloride Tablets, USP, 5 mg recalled by KVK-TechOxybutynin Chloride	Kvk-Tech	Other	Nationwide
8 Nov 2017Drug	CLASS II	Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg recalled	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
8 Feb 2017Drug	CLASS III	Finasteride Tablets, USP 5 mg recalled by Hetero Drugs Ltd. - Unit 1Finasteride	Hetero Drugs Ltd. - Unit 1	Other	NJ
29 Jul 2015Drug	CLASS II	Tamsulosin Hydrochloride Capsules, USP* recalled by Wockhardt Usa	Wockhardt Usa	Manufacturing (CGMP) Deviations	Nationwide

Should you stop taking Bladder & Prostate Medication?

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.

Alert me about Bladder & Prostate Medication

One email the day a new recall is posted for Bladder & Prostate Medication. Unsubscribe any time.

At a glance

Latest recall: 12 Aug 2026
First on record: 22 Jan 2014
Class I share: 2%
Ongoing: 5

Drug classes

Injectable & IV Drugs 4,627Pain Medication 1,518Creams, Ointments & Gels 930Blood Pressure Medication 837Compounded Drugs 721Eye Drops 600Hormones & Birth Control 495Antibiotics 492Allergy Medication 348Stomach & Acid Reflux Medication 313Cold & Cough Medicine 312Thyroid Medication 242

Recall classes

CLASS ISerious harm or death possible.

CLASS IITemporary or reversible harm.

CLASS IIIUnlikely to cause harm.