Teva metoprolol succinate 50 mg tablets failed dissolution specifications
Teva Pharmaceuticals is recalling six lots of Metoprolol Succinate Extended-Release Tablets 50 mg after the product failed dissolution specifications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: an extended-release cardiovascular medicine may not release its dose as specified, and no injuries are stated in the source.
Plain-English summary
Teva Pharmaceuticals USA, Inc is recalling Metoprolol Succinate Extended-Release Tablets, 50 mg, prescription only, in 100-tablet bottles (NDC 45963-676-11) and 1,000-tablet bottles (NDC 45963-676-96). About 67,043 bottles were distributed nationwide. The FDA has classified this recall as Class II.
The recall was initiated because the product failed dissolution specifications.
Affected product covers lots 0486G251, 0487G251, 0488G251, 0486G252, 0487G253 and 0488G252, all with an expiry date of 01/2027.
Patients and pharmacies can identify affected product by the NDC and lot numbers above, and may contact Teva Pharmaceuticals USA, Inc for further information.
The recalled product
- Product
- METOPROLOL SUCCINATE (METOPROLOL SUCCINATE)
- Brand
- METOPROLOL SUCCINATE
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Category
- Drug — Prescription tablet
- Affected units
- 67,043
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 (8)
- Lot#: a) 0486G251
- 0487G251
- 0488G251
- Exp.: 01/2027
- b) 0486G252
- 0487G253
- 0488G252
- Exp.: 01/2027.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Teva Pharmaceuticals USA, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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