Metoprolol succinate extended-release tablets failed dissolution testing during stability studies
Metoprolol Succinate Extended-Release Tablets 25 mg are being recalled because they failed dissolution acceptance criteria at the sixth month of long-term stability testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for an out-of-specification dissolution result found in stability testing, with no health consequence stated in the source.
Plain-English summary
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, packaged in 100-count bottles (NDC 70010-780-01) and 500-count bottles (NDC 70010-780-05), prescription only, manufactured by Granules India Limited of Hyderabad, India, are being recalled. The action covers 27,648 100-count bottles and 5,376 500-count bottles.
The stated reason is failed dissolution specifications: the product failed to meet dissolution acceptance criteria in the stability studies at the sixth month under long-term conditions of 25°C and 60% relative humidity. The FDA classified the action as Class II.
Affected lots are 1400008A and 1400008B, both expiring 12/31/2025. Distribution was nationwide in the USA.
Patients holding affected lots should speak to their pharmacist or prescriber before stopping treatment, and pharmacies should follow the instructions issued by the manufacturer.
The recalled product
- Product
- METOPROLOL SUCCINATE (METOPROLOL SUCCINATE)
- Brand
- METOPROLOL SUCCINATE
- Manufacturer
- Granules Pharmaceuticals Inc.
- Category
- Drug — Extended-release tablet
- Hazard
- dissolution-failure
- stability-study
- out-of-specification
- class-ii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # a)1400008A
- Exp Date: 12/31/2025
- b) 1400008B
UPCs (3)
- 0370010782013
- 0370010783010
- 0370010781016
Distribution
Distributed nationwide across the United States.
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