Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Jan 11, 2023 (4 years ago)

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: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.

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, 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

Affected NDCs 68001-0501-00 68001-0501-03

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.

ProductStrengthForm & routeLabelerType
Metoprolol Succinate
Metoprolol Succinate ER Tablets
NDC 68001-0501
METOPROLOL SUCCINATE 50 mg/1 Tablet, Film Coated, Extended Release
Oral
BluePoint Laboratories Rx
Recalling firm
Amerisource Health Services LLC
NDC code
68001-501-00
Origin
OH, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0269-2023 · 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

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Ongoing Cross-contamination Amerisource Health Services LLC D-0537-2026
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