Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0014-2016·Announced 2015-10-21

Actavis Recalls Metformin Hydrochloride Extended-Release Tablets for Dissolution Failure

Actavis is recalling 13,284 bottles of Metformin Hydrochloride Extended-Release Tablets, 1000 mg, because they failed dissolution specifications at the 8-hour timepoint.

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, which typically involves a temporary or medically reversible adverse health consequence. The source text does not report any illnesses or injuries, and the hazard is a quality specification failure rather than a high-risk pathogen or structural defect.

Plain-English summary

Actavis Laboratories, FL, Inc. is recalling 13,284 bottles of Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count. The product is prescription-only and was distributed nationwide and in Puerto Rico.

The recall was initiated because the tablets failed dissolution specifications, specifically showing low out-of-specification results at the 8-hour timepoint. This defect may affect the release of the medication from the extended-release formulation.

Consumers with this product should contact their healthcare provider or pharmacist for guidance. The affected lot number is 1037736A with an expiration date of 03/18. The NDC is 0591-2720-60 and the UPC is 3 05912 72060 3.

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 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 0591-2720-60; UPC 3 05912 72060 3.
Manufacturer: Actavis Laboratories, FL, Inc.
Category: Drug — Prescription Medication
Hazard: dissolution-failure
Affected units: 13,284

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 (2)

Lot: 1037736A
Exp 03/18

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Actavis Laboratories, FL, Inc.

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Same hazard · dissolution failure