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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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.
The recall concerns Failed Dissolution Specifications. Dissolution testing assesses how quickly the drug releases its active ingredient in the body. A failure means the product may not release metoprolol at the expected rate, potentially affecting therapeutic effect.
1. Stop using the product immediately. 2. Consult your healthcare provider for guidance and potential alternatives. 3. Contact Teva Pharmaceuticals USA, Inc for recall guidance or your pharmacist. 4. If you experience adverse effects, report them to your clinician or MedWatch.
Company: Teva Pharmaceuticals USA, Inc. Message channel and hours not specified in the notice. For guidance refer to the FDA enforcement page or consult your pharmacist.
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