Food, drugs, devices › Granules Pharmaceuticals Inc.
Drug recall: Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-cou
Granules Pharmaceuticals Inc. (Chantilly, VA) initiated this drug recall on 24 Jun 2025; FDA lists 1 product record under event 97131, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 79% of the 322 drug enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Granules Pharmaceuticals Inc. has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Granules Pharmaceuticals Inc., Chantilly, VA.
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."
Distribution
"Nationwide in the USA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0510-2025 | 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, | 27,648 100-count Bottles; 5,376 500-count Bottles | Class II | Ongoing | 9 Jul 2025 |
Context
Other enforcement events for Granules Pharmaceuticals Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 26 Jan 2026 | Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 | Drug | Class II | 1 |
| 28 Aug 2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Exte | Drug | Class III | 5 |
| 30 Dec 2024 | Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules In | Drug | Class II | 1 |
| 18 Dec 2024 | Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 2015 | Drug | Class II | 1 |
| 31 Jul 2024 | Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, | Drug | Class II | 1 |
| 3 Jul 2020 | Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (N | Drug | Class II | 1 |
All 7 events for Granules Pharmaceuticals Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the USA."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.