CLASS II ONGOING Drug recall · Reported 9 Jul 2025 · FDA Enforcement Report
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg recalled
Granules Pharmaceuticals is recalling Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, distributed nationwide in the US. The recall was initiated on 24 Jun 2025 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-0510-2025
- FDA event ID
- 97131
- Recalling firm
- Granules Pharmaceuticals, Chantilly, VA
- Brand
- Metoprolol Succinate
- Manufacturer
- Granules Pharmaceuticals Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Jun 2025
- FDA classified
- 8 Jul 2025
- Reported
- 9 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 24 Jun 2025 | Recall initiated by company | |
| 8 Jul 2025 | Classified by FDA | +14 days |
| 9 Jul 2025 | Published in enforcement report | +1 day |
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: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
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, 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,
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it 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.
Which lots are affected?
Lot # a)1400008A, Exp Date: 12/31/2025; b) 1400008B, Exp Date: 12/31/2025
Where was it sold?
Nationwide in the 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Granules Pharmaceuticals
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Trazodone Hydrochloride, USP, 50 mg recalled by Granules PharmaceuticalsTrazodone Hydrochloride | Granules Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Granules Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Granules Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Granules Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Dextroamphetamine Saccharate recalled by Granules PharmaceuticalsDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Granules Pharmaceuticals | Potency & Assay | Nationwide |
Other Metoprolol recalls
All 40| 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 recalledMetoprolol Succinate | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, 200 mg recalledMetoprolol Succinate | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, 25 mg bottles recalledMetoprolol Succinate | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, 50 mg bottles recalledMetoprolol Succinate | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |