Tamsulosin recalls

The FDA has published 3 recalls involving Tamsulosin since 2015. The latest was reported on 21 Aug 2019. Most were for potency & assay. Wockhardt Usa 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 recalls3since 2015

Last 12 months0reported

Class I00% of total

Ongoing0latest 21 Aug 2019

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 3 100%Class III 0 0%

Why tamsulosin is recalled

Potency & Assay267%
Manufacturing (CGMP) Deviations133%

Companies

By year

2019267%
2015133%

All tamsulosin recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
21 Aug 2019Drug	CLASS II	Tamsulosin Hydrochloride Capsules, USP 4 mg recalledTamsulosin Hydrochloride	Macleods Pharma Usa	Potency & Assay	Nationwide
13 Mar 2019Drug	CLASS II	Tamsulosin Hydrochloride Capsules, USP, 4 mg recalledTamsulosin Hydrochloride	Ascend Laboratories	Potency & Assay	Nationwide
29 Jul 2015Drug	CLASS II	Tamsulosin Hydrochloride Capsules, USP* recalled by Wockhardt Usa	Wockhardt Usa	Manufacturing (CGMP) Deviations	Nationwide

Should you stop taking Tamsulosin?

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.