RecallRadar

FDA Drug recall D-1294-2014

INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinj…

On 2014-05-21 the FDA classified a Class II recall of INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinj… by Teva Pharmaceuticals Usa, citing CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1294-2014
ClassificationClass II
Statusterminated
Initiated2014-03-24
Published2014-05-21
Last updated2026-09-13 11:51 UTC
CompanyTeva Pharmaceuticals Usa
DistributionUS

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

Reason

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

Identifiers

code_infoTE32134, Exp. 02/15

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1294-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.