CLASS II Drug recall · Reported 8 Nov 2017 · FDA Enforcement Report

Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg recalled

Teva Pharmaceuticals USA is recalling Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, distributed nationwide in the US. The recall was initiated on 25 Oct 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: a) 1089376A, 1089382A, 1095210M, 1117768M, 1117769A, Exp. 11/17; 1128452A, 1128453A, 1137658A, 1154207A, 1156087A, Exp. 03/18; b) 1089379A, 1091533M, 1125206A, Exp. 11/17; 1128456A, 1147665A, 1154208A, 1156088A, Exp. 03/18.

Quantity recalled140,993 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-0069-2018
FDA event ID: 78364
Recalling firm: Teva Pharmaceuticals USA, North Wales, PA
Classification: Class II
Status: Terminated
Recall initiated: 25 Oct 2017
FDA classified: 2 Nov 2017
Reported: 8 Nov 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Bladder & Prostate Medication

Timeline

25 Oct 2017	Recall initiated by company
2 Nov 2017	Classified by FDA	+8 days
8 Nov 2017	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

Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count bottle (NDC 0591-3771-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA.

Where it was distributed

Nationwide in the USA and Puerto Rico.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.

Which lots are affected?

Lot Numbers: a) 1089376A, 1089382A, 1095210M, 1117768M, 1117769A, Exp. 11/17; 1128452A, 1128453A, 1137658A, 1154207A, 1156087A, Exp. 03/18; b) 1089379A, 1091533M, 1125206A, Exp. 11/17; 1128456A, 1147665A, 1154208A, 1156088A, Exp. 03/18.

Where was it sold?

Nationwide in the USA 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 Dutasteride recalls

All 4

Reported	Class	Recall	Company	Reason	Where
22 Jan 2020Drug	CLASS II	Dutasteride Capsules, 0.5 mg Dose recalled by AVKARE	Avkare	Potency & Assay	Nationwide
29 Jan 2014Drug	CLASS II	Dutasteride, Capsule, 0.5 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
29 Jan 2014Drug	CLASS II	Dutasteride, Capsule, 0.5 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states