Metoprolol Succinate Extended-Release Tablets — Class II drug recall D-0510-2025
Ongoing recall by Granules Pharmaceuticals Inc., reported 2025-07-09, distributed nationwide. Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability stu
| Recall number | D-0510-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Granules Pharmaceuticals Inc., Chantilly, VA, United States |
| Recall initiated | 2025-06-24 |
| Classified | 2025-07-08 |
| Reported by FDA | 2025-07-09 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 70010-0780, 70010-0780-01, 70010-0780-05, 70010-0780-10, 70010-0781, 70010-0781-01, 70010-0781-05, 70010-0781-10, 70010-0782, 70010-0782-01, 70010-0782-05, 70010-0782-10, 70010-0783, 70010-0783-01, 70010-0783-05, 70010-0783-10 |
| Expiration dates | 2025-12-31 |
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,
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0510-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.