Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Ongoing Initiated Jun 24, 2025 (16 months ago)

Metoprolol Succinate Extended-Release Tablets

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.

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, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, Hyderadab-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151,

Affected NDCs 70010-0780-01 70010-0780-05

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
NDC 70010-0780
25 mg/1 Tablet, Film Coated, Extended Release
Oral
Granules Pharmaceuticals Inc. Rx
Recalling firm
Granules Pharmaceuticals Inc.
NDC code
70010-780-01
Origin
VA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0510-2025 · 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.

Other Metoprolol recalls

See all

Other recalls by Granules Pharmaceuticals Inc.

All 2025 recalls