CLASS III Drug recall · Reported 12 Jun 2013 · FDA Enforcement Report

Disulfiram Tablets USP 250 mg recalled by Teva Pharmaceuticals USA

Teva Pharmaceuticals USA is recalling Disulfiram Tablets USP 250 mg, distributed nationwide in the US. The recall was initiated on 19 Mar 2013 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesNDC 0093-5035-01, Lot numbers 14064211A, exp 3/2014; 14064311A, exp 3/2014; 14064411A, exp 3/2014; 14064511A, exp 3/2014; 14090312A, exp 4/2015; 14092512A, exp 4/2015; 14092712A, exp 4/2015; 14094612A, exp 4/2015; 14099412A, exp 4/2015; 14099612B, exp 4/2015; 14099712A, exp 5/2015; 14110111A, exp 5/2014; 14110211A, exp 5/2014; 14110311A, exp 5/2014; 14110411A, exp 5/2014 and 34090212A, exp 4/2015.

Quantity recalled68,322 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-578-2013
FDA event ID: 64680
Recalling firm: Teva Pharmaceuticals USA, Sellersville, PA
Classification: Class III
Status: Terminated
Recall initiated: 19 Mar 2013
FDA classified: 6 Jun 2013
Reported: 12 Jun 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations

Timeline

19 Mar 2013	Recall initiated by company
6 Jun 2013	Classified by FDA	+79 days
12 Jun 2013	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

CGMP Deviation; cotton coil is missing in some packaged bottles

Product as listed by the FDA

Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA --- NDC 0093-5035-01

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviation; cotton coil is missing in some packaged bottles

Which lots are affected?

NDC 0093-5035-01, Lot numbers 14064211A, exp 3/2014; 14064311A, exp 3/2014; 14064411A, exp 3/2014; 14064511A, exp 3/2014; 14090312A, exp 4/2015; 14092512A, exp 4/2015; 14092712A, exp 4/2015; 14094612A, exp 4/2015; 14099412A, exp 4/2015; 14099612B, exp 4/2015; 14099712A, exp 5/2015; 14110111A, exp 5/2014; 14110211A, exp 5/2014; 14110311A, exp 5/2014; 14110411A, exp 5/2014 and 34090212A, exp 4/2015.

Where was it sold?

Nationwide

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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.

More recalls from Teva Pharmaceuticals USA

All 281

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21 Oct 2026Drug	CLASS II	Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets recalledMetoclopramide	Teva Pharmaceuticals USA	Other	Nationwide
9 Sep 2026Drug	CLASS II	traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride	Teva Pharmaceuticals USA	Other	Nationwide
13 May 2026Drug	CLASS II	Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate	Teva Pharmaceuticals USA	Sterility	Nationwide
29 Apr 2026Drug	CLASS II	Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
15 Apr 2026Drug	CLASS II	Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin	Teva Pharmaceuticals USA	Potency & Assay	4 states

Other Disulfiram recalls

All 3

Reported	Class	Recall	Company	Reason	Where
8 Jul 2015Drug	CLASS III	Disulfiram tablets, USP, 500 mg recalled by Qualitest Pharmaceuticals	Qualitest Pharmaceuticals	Potency & Assay	Nationwide
22 Jan 2014Drug	CLASS II	Disulfiram Tablet, 250 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states