Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1294-2014·Announced 2014-05-21

Teva Recalls Indomethacin Capsules Due to Manufacturing Quality Deviations

Teva Pharmaceuticals USA is recalling 7,694 bottles of Indomethacin Capsules USP, 25 mg, due to CGMP deviations and laboratory testing failures.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a manufacturing quality deviation (CGMP) without reported harm, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls where injury has not been reported.

Plain-English summary

Teva Pharmaceuticals USA is recalling 7,694 bottles of Indomethacin Capsules USP, 25 mg, 100 count bottles. The product is prescription-only and was manufactured in India by EMCure Pharmaceuticals Ltd. for Teva Pharmaceuticals USA. The affected lot has the code TE32134 and an expiration date of 02/15.

The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations. Specifically, laboratory testing was not followed in accordance with Good Manufacturing Practice (GMP) requirements. This indicates a failure in the quality control processes required to ensure the safety and efficacy of the medication.

The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled Indomethacin Capsules and contact their healthcare provider for guidance on alternative treatment options. The product should be returned to the pharmacy or disposed of according to local regulations.

The recalled product

Product: INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Prescription Medication
Hazard: cgmp-deviation
quality-control-failure
Affected units: 7,694

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

TE32134
Exp. 02/15

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · cgmp deviation