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.
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, 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
- 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
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