Metoprolol Succinate Extended-Release Tablets recall
FDA recall D-0510-2025 · initiated Jun 24, 2025
Granules Pharmaceuticals Inc. recalled Metoprolol Succinate Extended-Release Tablets in Jun 2025 — an FDA Class II recall (D-0510-2025) because Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
May cause temporary or medically reversible harm; low probability of serious harm.
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.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 27,648 100-count Bottles; 5,376 500-count Bottles
Details
- Product
- 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,
- Recalling company
- Granules Pharmaceuticals Inc
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA.
- Initiated
- Jun 24, 2025
- FDA report date
- Jul 9, 2025
Frequently asked
- Was Metoprolol Succinate Extended-Release Tablets recalled?
- Granules Pharmaceuticals Inc. recalled Metoprolol Succinate Extended-Release Tablets in Jun 2025 — an FDA Class II recall (D-0510-2025) because Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Metoprolol Succinate Extended-Release Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0510-2025 was: Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
- Is a recalled Metoprolol Succinate Extended-Release Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Metoprolol Succinate Extended-Release Tablets are affected?
- Distributed: Nationwide in the USA.. The recall covers these lots — Lot # a)1400008A, Exp Date: 12/31/2025; b) 1400008B, Exp Date: 12/31/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0510-2025.