CLASS II Drug recall · Reported 11 Jan 2017 · FDA Enforcement Report

Torsemide Tablets, 5 mg recalled by Apotex

Apotex is recalling Torsemide Tablets, 5 mg. The recall was initiated on 14 Dec 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: KW8378; Exp. Date 05/17.

Quantity recalled13,179 bottles (1,317,900 tablets)

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-0245-2017
FDA event ID: 75964
Recalling firm: Apotex, Weston, FL
Classification: Class II
Status: Terminated
Recall initiated: 14 Dec 2016
FDA classified: 2 Jan 2017
Reported: 11 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations

Timeline

14 Dec 2016	Recall initiated by company
2 Jan 2017	Classified by FDA	+19 days
11 Jan 2017	Published in enforcement report	+9 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

Product as listed by the FDA

Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0232-01

Where it was distributed

United States

Questions about this recall

Is Torsemide Tablets, 5 mg recalled?

Yes. Apotex recalled Torsemide Tablets, 5 mg on 14 Dec 2016. The recall is Class II and its status is Terminated. Recall number D-0245-2017.

Why was it recalled?

CGMP Deviations

Which lots are affected?

Lot #: KW8378; Exp. Date 05/17.

Where was it sold?

United States

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 Torsemide recalls

All 4

Reported	Class	Recall	Company	Reason	Where
11 Jan 2017Drug	CLASS II	Torsemide Tablets, 20 mg recalled by Apotex	Apotex	Manufacturing (CGMP) Deviations	FL
22 Jan 2014Drug	CLASS II	Torsemide Tablet, 10 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
22 Jan 2014Drug	CLASS II	Torsemide Tablet, 10 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states