Metoprolol Succinate Extended-Release Tablets Recalled for Failed Dissolution Specification
Ascend Laboratories is recalling 2,628 bottles of Metoprolol Succinate Extended-Release Tablets (50 mg) nationwide due to failed dissolution specification. The tablets may not dissolve properly, preventing proper medication absorption.
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 drug recall for a manufacturing defect (failed dissolution) that could prevent medication absorption and reduce drug efficacy. As no illnesses or hospitalizations have been reported, this qualifies as High severity per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Ascend Laboratories, LLC is recalling Metoprolol Succinate Extended-Release Tablets (50 mg) due to a failed dissolution specification. The recall affects 2,628 bottles distributed nationwide and in Puerto Rico under Lot Numbers 21141321 and 21141322 (expiration date 01/31/2023).
The tablets have failed to meet the dissolution specification, which means they may not dissolve at the appropriate rate in the gastrointestinal system. This defect could prevent proper drug absorption and compromise medication efficacy.
Consumers with affected lot numbers should contact their healthcare provider or pharmacist for guidance on this recall.
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 (3)
- Lot#: 21141321
- 21141322
- Exp 01/31/2023.
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · METOPROLOL SUCCINATE
- ModerateMetoprolol Succinate Extended-Release Tablets Recalled Due to Failed Dissolution
FDA (Drugs) · 2026-05-20
- HighMetoprolol Succinate Extended-Release Tablets Recalled for Storage Temperature Deviations
FDA (Drugs) · 2024-01-03
- HighMetoprolol Succinate ER Tablets Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2023-02-22
- HighPrescription Metoprolol Succinate Extended-Release Tablets Recalled for Failed Dissolution
FDA (Drugs) · 2023-02-01
- ModerateMetoprolol Succinate Tablets Recalled for Failed Dissolution Specification
FDA (Drugs) · 2023-02-01
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- ModeratePrimidone Tablets Recalled Due to API Cross-Contamination
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- SevereErythromycin Tablets Recalled for Impurity Above Acceptable Limits
FDA (Drugs) · 2026-05-27