CLASS II Drug recall · Reported 21 May 2014 · FDA Enforcement Report

Indomethacin Capsules USP, 50 mg, a) recalled by Teva Pharmaceuticals U

Teva Pharmaceuticals USA is recalling Indomethacin Capsules USP, 50 mg, a), (, distributed nationwide in the US. The recall was initiated on 24 Mar 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesTE38139, Exp. 08/16, TE39022, Exp. 09/16,

Quantity recalled5812 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-1295-2014
FDA event ID: 67811
Recalling firm: Teva Pharmaceuticals USA, Horsham, PA
Classification: Class II
Status: Terminated
Recall initiated: 24 Mar 2014
FDA classified: 12 May 2014
Reported: 21 May 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations

Timeline

24 Mar 2014	Recall initiated by company
12 May 2014	Classified by FDA	+49 days
21 May 2014	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; laboratory testing was not followed in accordance with GMP requirements.

Product as listed by the FDA

INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.

Which lots are affected?

TE38139, Exp. 08/16, TE39022, Exp. 09/16,

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 67811

This product is part of a recall event; the main page for the event is Indomethacin Capsules USP, 25 mg recalled by Teva Pharmaceuticals U.

Reported	Class	Recall	Company	Reason	Where
21 May 2014	CLASS II	Indomethacin Capsules USP, 25 mg recalled by Teva Pharmaceuticals U	Teva Pharmaceuticals USA	Manufacturing (CGMP) Deviations	Nationwide
21 May 2014	CLASS II	Methyldopa Tablets USP, 500 mg recalled by Teva Pharmaceuticals U	Teva Pharmaceuticals USA	Manufacturing (CGMP) Deviations	Nationwide
21 May 2014	CLASS II	Glyburide and Metformin Hydrochloride Tablets USP, 5mg/500mg recalled	Teva Pharmaceuticals USA	Manufacturing (CGMP) Deviations	Nationwide

More recalls from Teva Pharmaceuticals USA

All 281

Reported	Class	Recall	Company	Reason	Where
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 Indomethacin recalls

All 9

Reported	Class	Recall	Company	Reason	Where
11 Jun 2025Drug	CLASS II	Indomethacin Extended-Release Capsules, USP, 75 mg recalledIndomethacin	Amerisource Health Services	Manufacturing (CGMP) Deviations	Nationwide
28 May 2025Drug	CLASS II	Indomethacin Extended-Release Capsules USP, 75 mg recalled by KVK TechIndomethacin	KVK Tech	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Indomethacin Extended-Release Capsules, 75mg recalledIndomethacin	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
4 Sep 2024Drug	CLASS II	Indomethacin Extended-Release Capsules, USP, 75 mg recalledIndomethacin	Glenmark Pharmaceuticals Inc., USA	Potency & Assay	Nationwide
6 Dec 2023Drug	CLASS II	Indomethacin 25mg Capsules recalled by Glenmark PharmaceuticalsIndomethacin	Glenmark Pharmaceuticals Inc., USA	Packaging Defects	Nationwide