Dr. Reddy's Recalls Metoprolol Succinate Tablets for Dissolution Failure
Dr. Reddy's is recalling specific lots of Metoprolol Succinate Extended Release Tablets because they failed dissolution testing at 18 months.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score (2) when no hospitalizations or serious injuries are reported, aligning with the rubric for minor labeling errors or low-risk contamination/precautionary recalls.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 13,560 bottles of Metoprolol Succinate Extended Release Tablets, USP 25 mg. The affected product is distributed nationwide and includes Lot # C206578 (Exp. 05/2014) and Lot # C207415 (Exp. 06/2014). The recall is due to a failure of the dissolution test observed at the 18-month time point.
The FDA has classified this recall as Class II, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The source text does not report any illnesses or injuries associated with this recall.
Consumers who have these specific lots of Metoprolol Succinate should contact their healthcare provider or pharmacist for guidance on alternative medication or further instructions. The product is a prescription-only medication manufactured by Dr. Reddy's Laboratories Limited in India.
The recalled product
- Product
- METOPROLOL SUCCINATE (METOPROLOL SUCCINATE)
- Brand
- METOPROLOL SUCCINATE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 13,560
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 (1)
- Lot # C206578 Exp. 05/2014 Lot # C207415 Exp. 06/2014
UPCs (2)
- 0355111466017
- 0355111467014
Distribution
Distributed nationwide across the United States.
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