CLASS II Drug recall · Reported 14 Aug 2013 · FDA Enforcement Report

Terazosin Hydrochloride Capsules,10 mg recalled

Teva Pharmaceuticals USA is recalling Terazosin Hydrochloride Capsules,10 mg, distributed nationwide in the US. The recall was initiated on 23 Jul 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # N07321, Exp 6/14

Quantity recalled6267 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-842-2013
FDA event ID: 65826
Recalling firm: Teva Pharmaceuticals USA, Sellersville, PA
Classification: Class II
Status: Terminated
Recall initiated: 23 Jul 2013
FDA classified: 6 Aug 2013
Reported: 14 Aug 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects

Timeline

23 Jul 2013	Recall initiated by company
6 Aug 2013	Classified by FDA	+14 days
14 Aug 2013	Published in enforcement report	+8 days

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

Reason for recall

Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (HCl) 10mg Capsules contained Terazosin HCl 5 mg Capsules

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-4339-01

Where it was distributed

Nationwide and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (HCl) 10mg Capsules contained Terazosin HCl 5 mg Capsules

Which lots are affected?

Lot # N07321, Exp 6/14

Where was it sold?

Nationwide and Puerto Rico

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 26 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 Terazosin recalls

All 3

Reported	Class	Recall	Company	Reason	Where
29 Jan 2014Drug	CLASS II	Terazosin HCL, Capsule, 5 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
20 Mar 2013Drug	CLASS II	Terazosin Hydrochloride Capsules, 2 mg recalled	Teva Pharmaceuticals USA	Packaging Defects	Nationwide