Teva Pharmaceuticals recalled 67,043 bottles of Metoprolol Succinate Extended-Release Tablets, 50 mg, distributed nationwide. The FDA enforcement report cites Failed Dissolution Specifications as the hazard. Health care providers and patients should stop using this product immediately and contact Teva for guidance.
Failed Dissolution Specifications
Consumers and healthcare providers should stop using this product immediately. Contact Teva Pharmaceuticals USA, Inc or your healthcare provider for guidance. Notification method: Letter
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Metoprolol succinate extended-release tablets are used to treat high blood pressure and other heart-related conditions. They are prescribed and dispensed by healthcare professionals.
The dissolution failure means the medicine may not release the active ingredient as designed, potentially reducing effectiveness or causing unpredictable effects.
This recall is not described as part of a broader industry pattern in the notice.
Patients may experience reduced therapeutic effect or unpredictable blood pressure control. The recall impacts a large nationwide distribution and requires immediate clinician guidance.
NDC and lot numbers are on the bottle label near the bottom or back panel.
Recall status is active. No specific replacement timeline provided. Monitor Teva FDA notices for updates.
Keep the recall notice, bottle labels, and all correspondence with Teva. Document dates, conversations, and any adverse effects.
NDCs: 45963-676-11 (50 mg, 100-tablet bottles) and 45963-676-96 (50 mg, 1,000-tablet bottles). Sold nationwide. Rx Only. Manufacturer: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Quantity: 67,043 bottles. Price: Unknown. Model/Lot information: Lot numbers a) 0486G251, 0487G251, 0488G251; Exp. 01/2027. Lot numbers b) 0486G252, 0487G253, 0488G252; Exp. 01/2027.
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