Class II · Moderate risk
Ascend Laboratories
Failed Dissolution Specifications
Metoprolol Succinate Extended-Release Tablets (Metoprolol Succinate ER Tablets)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, 07054, NDC 67877-590-01.
Affected NDC
67877-0590-01
Compare with the code on your package — it is the most precise check available.
Drug: Metoprolol Category: Blood Pressure Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Metoprolol Succinate Metoprolol Succinate ER Tablets NDC 67877-0590 |
METOPROLOL SUCCINATE 25 mg/1 | Tablet, Film Coated, Extended Release Oral |
Ascend Laboratories, LLC | Rx |
- Recalling firm
- Ascend Laboratories, LLC
- NDC code
- 67877-590-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0393-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Metoprolol recalls
See all
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
Other recalls by Ascend Laboratories, LLC
All 2022 recalls
Class III · Low risk
Dabigatran Etexilate Capsules
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Class III · Low risk
Dabigatran Etexilate Capsules
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Class III · Low risk
Dabigatran Etexilate Capsules
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Class II · Moderate risk
Amlodipine and Olmesartan Medoxomil Tablets
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
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