CLASS II Drug recall · Reported 12 Mar 2014 · FDA Enforcement Report

Teva Ethambutol Hydrochloride Tablets, USP, 400 mg recalled

Teva Pharmaceuticals USA is recalling Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, distributed nationwide in the US. The recall was initiated on 24 Jan 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 34013698A, Exp. 01/16. Lot # 34013699A, Exp. 01/16. Lot # 34013700A, Exp. 01/16. Lot # 34013756A, Exp. 01/16.

Quantity recalled10405 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-1092-2014
FDA event ID: 67412
Recalling firm: Teva Pharmaceuticals USA, Horsham, PA
Classification: Class II
Status: Terminated
Recall initiated: 24 Jan 2014
FDA classified: 28 Feb 2014
Reported: 12 Mar 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations

Timeline

24 Jan 2014	Recall initiated by company
28 Feb 2014	Classified by FDA	+35 days
12 Mar 2014	Published in enforcement report	+12 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: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.

Product as listed by the FDA

Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02.

Where it was distributed

Nationwide.

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.

Which lots are affected?

Lot # 34013698A, Exp. 01/16. Lot # 34013699A, Exp. 01/16. Lot # 34013700A, Exp. 01/16. Lot # 34013756A, Exp. 01/16.

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 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.

Other products in this recall event

3 other products · FDA event 67412

This product is part of a recall event; the main page for the event is Teva Hydroxyzine Pamoate Capsules, USP, 100 mg recalled.

Reported	Class	Recall	Company	Reason	Where
12 Mar 2014	CLASS II	Teva Hydroxyzine Pamoate Capsules, USP, 100 mg recalledHydroxyzine Pamoate	Teva Pharmaceuticals USA	Manufacturing (CGMP) Deviations	Nationwide
12 Mar 2014	CLASS II	Teva Dextroamphetamine Saccharate, Amphetamine Asparate recalledDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Teva Pharmaceuticals USA	Manufacturing (CGMP) Deviations	Nationwide
12 Mar 2014	CLASS II	Teva Hydroxyzine Pamoate Capsules, USP, 25 mg recalledHydroxyzine Pamoate	Teva Pharmaceuticals USA	Manufacturing (CGMP) Deviations	Nationwide

More recalls from Teva Pharmaceuticals USA

All 280

Reported	Class	Recall	Company	Reason	Where
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
15 Apr 2026Drug	CLASS II	Isotretinoin Capsules, USP, 40 mg Prescription Pacs recalledIsotretinoin	Teva Pharmaceuticals USA	Potency & Assay	4 states