The Recall Desk
ModerateFDA (Drugs)·D-0101-2019·Announced 2018-10-31

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

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

What this means for you

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 voluntary precautionary recall.

Plain-English summary

Teva Pharmaceuticals USA is recalling specific lots of Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottles. The recall is due to a defective delivery system where some tablets may be missing the laser drilling required for proper drug release. This defect might affect how the medication is released in the body.

The affected product is identified by NDC 00591-2412-19. The specific lots subject to recall are 1240400A (Expiration 05/2019) and 1293935M (Expiration 12/2019). The product was manufactured by Actavis Laboratories FL, Inc. and distributed by Actavis Pharma, Inc. It was distributed throughout the United States, with bulk product also distributed to Takeda in Deerfield, IL, which may have led to further distribution.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled description, it should be discontinued and returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider for alternative treatment options if they are currently using the recalled product.

The recalled product

Product
Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2412-19
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Prescription Medication
Hazard

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 (4)

  • Lot #: 1240400A
  • Exp 05/2019
  • 1293935M
  • Exp 12/2019

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 →

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