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

Methyldopa Tablets USP, 500 mg recalled by Teva Pharmaceuticals U

Teva Pharmaceuticals USA is recalling Methyldopa Tablets USP, 500 mg, 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 codesTE36053A,TE36063A, Exp. 06/16

Quantity recalled22820 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: D1292-2014
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

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

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?

TE36053A,TE36063A, Exp. 06/16

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	Glyburide and Metformin Hydrochloride Tablets USP, 5mg/500mg recalled	Teva Pharmaceuticals USA	Manufacturing (CGMP) Deviations	Nationwide
21 May 2014	CLASS II	Indomethacin Capsules USP, 50 mg, a) recalled by Teva Pharmaceuticals U	Teva Pharmaceuticals USA	Manufacturing (CGMP) Deviations	Nationwide

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