Prescription Metoprolol Succinate Extended-Release Tablets Recalled for Failed Dissolution
Ascend Laboratories recalls 49,632 bottles of Metoprolol Succinate extended-release tablets (25 mg) nationwide and in Puerto Rico due to failure to meet dissolution specifications that could reduce drug effectiveness.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a prescription cardiac medication where the manufacturing defect (failed dissolution specification) could prevent proper drug absorption and therapeutic effect. Although no illnesses or injuries have been reported, the defect creates a risk of harm to patients dependent on this essential medication.
Plain-English summary
Ascend Laboratories, LLC is recalling 49,632 bottles of Metoprolol Succinate Extended-Release Tablets, USP 25 mg (NDC 67877-590-01) due to failure to meet dissolution specifications. The affected lot numbers are 21143094, 21143095, 21143119, 21143121, and 21142389, all expiring March 31, 2023. These tablets were manufactured by Alkem Laboratories Ltd. in Mumbai, India and distributed nationwide and in Puerto Rico.
The tablets failed to meet dissolution specifications, which define how the medication should dissolve in the body. This manufacturing defect could prevent proper absorption of the active ingredient, potentially reducing the effectiveness of the medication for patients.
Consumers who have bottles with the affected lot numbers should contact their healthcare provider or pharmacist. Patients should not stop taking their medication without consulting with their healthcare provider.
The recalled product
- Product
- METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
- Brand
- METOPROLOL SUCCINATE
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug
- Hazard
- dissolution-failure
- 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 (6)
- Lot #s: 21143094
- 21143095
- 21143119
- 21143121
- 21142389
- Exp 03/31/2023.
Distribution
Distributed nationwide across the United States.
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