CLASS II Drug recall · Reported 22 Feb 2023 · FDA Enforcement Report
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg recalled
Amerisource Health Services is recalling Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, distributed nationwide in the US. The recall was initiated on 11 Jan 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0269-2023
- FDA event ID
- 91528
- Recalling firm
- Amerisource Health Services, Columbus, OH
- Brand
- Metoprolol Succinate
- Manufacturer
- BluePoint Laboratories
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jan 2023
- FDA classified
- 15 Feb 2023
- Reported
- 22 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 11 Jan 2023 | Recall initiated by company | |
| 15 Feb 2023 | Classified by FDA | +35 days |
| 22 Feb 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-count bottle, NDC 68001-501-03. Manufactured by Alkem Laboratories Ltd., India. For BluePoint Laboratories
Where it was distributed
Nationwide USA
Questions about this recall
Is Metoprolol Succinate Extended-Release Tablets, USP, 50 mg recalled?
Yes. Amerisource Health Services recalled Metoprolol Succinate Extended-Release Tablets, USP, 50 mg on 11 Jan 2023. The recall is Class II and its status is Terminated. Recall number D-0269-2023.
Why was it recalled?
Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.
Which lots are affected?
Lots: (a) 21143211, EXP 03/31/2023; (b) 21143185, 21143193, EXP 02/28/2023
Where was it sold?
Nationwide USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Metoprolol Succinate Er Tablets recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* recalledMetoprolol Succinate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, USP 50 mg recalledMetoprolol Succinate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, USP 50 mg recalledMetoprolol Succinate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, USP 25 mg recalledMetoprolol Succinate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, USP, 25 mg recalledMetoprolol Succinate | Ascend Laboratories | Potency & Assay | Nationwide |