Metoprolol Succinate Extended-Release Tablets Recalled Due to Failed Dissolution
Ascend Laboratories is recalling 17,304 bottles of Metoprolol Succinate Extended-Release 25 mg tablets (Lot #25140859, expiring Jan 2027) distributed nationwide because the tablets failed dissolution specifications, which may affect drug effectiveness.
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: This is an FDA Class II recall. The hazard is a quality/manufacturing defect (failed dissolution specifications) with no reported illnesses or injuries; the risk is that the drug may not be effective as intended. Under the rubric, Class II recalls without hospitalization reports and without reported illness typically score 2 (Moderate).
Plain-English summary
Ascend Laboratories, LLC is recalling Metoprolol Succinate Extended-Release Tablets, USP, 25 mg (NDC 67877-590-01), manufactured by Alkem Laboratories Ltd. in India and distributed by Ascend Laboratories in Parsippany, NJ. The recalled product consists of 17,304 bottles containing 100 tablets each from Lot #25140859, with an expiration date of January 2027.
The recall was initiated because the tablets failed to meet dissolution specifications. Dissolution is the rate at which a tablet releases its active ingredient in the body; failure to meet specifications may result in the drug not being released properly and could affect the medication's effectiveness in treating the condition for which it was prescribed.
Patients currently taking this medication should contact their healthcare provider or pharmacist to determine whether they may have received affected tablets and to discuss whether they need a replacement supply or alternative treatment. Consumers who have this medication should not stop taking it without consulting their healthcare provider, as abruptly stopping a beta-blocker such as metoprolol can be harmful.
The recalled product
- Product
- METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
- Brand
- METOPROLOL SUCCINATE
- Manufacturer
- Ascend Laboratories, LLC
- Hazard
- dissolution-defect
- reduced-efficacy
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 # 25140859
- Exp. Date: Jan 2027
Distribution
Distributed nationwide across the United States.