Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0100-2019·Announced 2018-10-31

Teva Recalls Metformin Hydrochloride Extended Release Tablets Due to Defective Delivery System

Teva Pharmaceuticals USA is recalling 82,291 bottles of Metformin Hydrochloride Extended Release Tablets 1000 mg because some tablets may be missing laser drilling, which could affect drug release.

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, and the hazard involves a potential defect in drug release without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Teva Pharmaceuticals USA is recalling 82,291 bottles of Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count, Rx only. The product is manufactured by Actavis Laboratories FL, Inc. and distributed by Actavis Pharma, Inc. The recall involves specific lots: 1139500A (Exp 04/2019), 1240343A, 1248901M, and 1256614M (Exp 05/2020).

The recall was initiated due to a defective delivery system. There is a potential for some tablets to be missing the laser drilling, which might affect drug release. The product was distributed throughout the United States, with bulk product also distributed to Takeda in Deerfield, IL, and potentially further distributed.

Consumers and healthcare providers should check their inventory for the affected NDC 00591-2720-60 and the listed lot numbers. If the product is found, it should be returned to the pharmacy or distributor for a refund or replacement, per standard recall procedures.

The recalled product

Product: Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2720-60
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Prescription Medication
Hazard: defective-delivery-system
drug-release-variability
Affected units: 82,291

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 (6)

Lot #: 1139500A
Exp 04/2019
1240343A
1248901M
1256614M
Exp 05/2020

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 7 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 7 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

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