RecallRadar

FDA Drug recall D1292-2014

METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwa…

On 2014-05-21 the FDA classified a Class II recall of METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwa… 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 numberD1292-2014
ClassificationClass II
Statusterminated
Initiated2014-03-24
Published2014-05-21
Last updated2026-09-13 11:51 UTC
CompanyTeva Pharmaceuticals Usa
DistributionUS

Product

METHYLDOPA Tablets USP, 500 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 0093-2932-01

Reason

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

Identifiers

code_infoTE36053A,TE36063A, Exp. 06/16

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:%22D1292-2014%22

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