Teva Recalls Metoprolol Succinate Extended Release Tablets Due to Dissolution Failure
Teva Pharmaceuticals USA is recalling 53,451 bottles of Metoprolol Succinate Extended Release Tablets 50 mg because routine stability testing revealed out-of-specification dissolution results.
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: The recall is classified as FDA Class II, which is remote or theoretical risk of temporary or medically reversible adverse health consequences. The hazard is a quality control issue (dissolution) rather than a direct safety hazard like contamination or mislabeling of a critical allergen.
Plain-English summary
Teva Pharmaceuticals USA is recalling 53,451 bottles of Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottles. The product is prescription-only and was manufactured by Actavis Laboratories FL, Inc. and distributed by Actavis Pharma, Inc. The specific lot number is 1220211M with an expiration date of 02/2019.
The recall was initiated because an out-of-specification dissolution test result was obtained during routine stability testing. This indicates that the tablets may not dissolve at the rate required by the United States Pharmacopeia (USP) standards, which could affect the drug's efficacy.
The affected product was distributed nationwide in the U.S.A., including Puerto Rico. Patients and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the pharmacy or healthcare provider for replacement or refund.
The recalled product
- Product
- Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Cardiovascular
- Hazard
- Affected units
- 53,451
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 (2)
- Lot # 1220211M
- Exp 02/2019
Distribution
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