Agency classClass IIOur severity:Moderate FDA (Drugs)·D1292-2014·Announced 2014-05-21

Teva Recalls Methyldopa Tablets Due to Manufacturing Deviations

Teva Pharmaceuticals USA is recalling Methyldopa Tablets USP, 500 mg, due to CGMP deviations and laboratory testing not following 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 due to CGMP deviations and laboratory testing issues, which fits the rubric for moderate severity involving voluntary precautionary recalls or minor labeling/process errors without reported illness.

Plain-English summary

Teva Pharmaceuticals USA is recalling Methyldopa Tablets USP, 500 mg, 100 count bottles (NDC 0093-2932-01). The affected products were manufactured in India by EMCure Pharmaceuticals Ltd. and distributed nationwide. The recall involves 22,820 bottles with lot codes TE36053A and TE36063A and an expiration date of 06/16.

The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations. Specifically, laboratory testing was not conducted in accordance with GMP requirements. This classification is designated as Class II by the FDA.

Consumers and healthcare providers should discontinue use of the affected Methyldopa tablets and contact their healthcare provider for alternatives. The recall is limited to the specific lot codes and expiration date listed above.

The recalled product

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
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Prescription Medication
Hazard: cgmp-deviation
testing-non-compliance
Affected units: 22,820

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 (3)

TE36053A
TE36063A
Exp. 06/16

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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Same hazard · cgmp deviation