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.
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 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
- 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.
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