Metoprolol Succinate ER Tablets Recall for Failed Dissolution
American Health Packaging is recalling Metoprolol Succinate Extended-Release Tablets 50 mg nationwide due to failed dissolution specifications. The affected lots may not release the medication properly, potentially reducing its effectiveness.
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 source identifies this as an FDA Class II recall. The hazard is a dissolution failure that could reduce therapeutic effectiveness, but no reported illnesses or injuries are mentioned in the source text. Class II recalls with no reported harm typically fall in the Moderate range.
Plain-English summary
American Health Packaging is recalling Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottles nationwide. The recall affects six specific lot numbers with expiration dates in February and March 2023.
The recall is due to failed dissolution specifications. When a tablet fails to dissolve as intended, the active ingredient may not be released into the body at the proper rate, which could compromise the medication's therapeutic effectiveness for patients relying on this blood pressure medication.
The affected lot numbers are 21141983, 21141984, 21141985 (expiring 03/31/2023) and 21142017, 21142018, 21142019 (expiring 02/28/2023). The manufacturer is Alkem Laboratories Ltd., Mumbai, India, and the product was distributed by American Health Packaging. A total of 6,637 bottles have been recalled.
Patients currently taking tablets from the affected lots should contact their healthcare provider or pharmacist for guidance. Do not stop taking the medication without medical advice, as abrupt discontinuation of metoprolol can be harmful.
The recalled product
- Product
- METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
- Brand
- METOPROLOL SUCCINATE
- Manufacturer
- American Health Packaging
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 (7)
- Lots# 21141983
- 21141984 and 21141985
- Exp 03/31/2023
- Lots# 21142017
- 21142018
- 21142019
- Exp 02/28/2023
UPCs (2)
- 0368001503006
- 0368001500005
Distribution
Distributed nationwide across the United States.
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