Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1295-2014·Announced 2014-05-21

Teva Recalls Indomethacin Capsules Due to Manufacturing Quality Deviations

Teva Pharmaceuticals USA is recalling Indomethacin Capsules USP, 50 mg, because laboratory testing was not conducted in accordance with Good Manufacturing Practice (GMP) requirements.

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, which typically involves a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is related to process deviations rather than a confirmed high-risk pathogen or structural defect.

Plain-English summary

Teva Pharmaceuticals USA is recalling Indomethacin Capsules USP, 50 mg, in 100-count and 500-count bottles. The recall involves specific lot numbers TE38139 (expiration 08/16) and TE39022 (expiration 09/16). The product was manufactured in India by EMCure Pharmaceuticals Ltd. for Teva Pharmaceuticals USA.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, laboratory testing was not followed in accordance with GMP requirements. This deviation raises concerns about the quality and safety of the medication, as the necessary testing to ensure product integrity was not performed as required.

The affected product was distributed nationwide. Consumers who have these specific bottles of Indomethacin Capsules should stop using them and contact their healthcare provider or pharmacist for guidance. They should also contact Teva Pharmaceuticals USA for information on how to return the product for a refund.

The recalled product

Product: 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
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Prescription Medication
Hazard: cgmp-deviation
quality-control
Affected units: 5,812

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 (4)

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

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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