Teva Pharmaceuticals Recalls Metoprolol Succinate Extended-Release Tablets Due to Dissolution Failure
Teva Pharmaceuticals USA, Inc. has voluntarily recalled over 67,000 bottles of Metoprolol Succinate Extended-Release Tablets after the medication failed dissolution specifications.
What Happened
Teva Pharmaceuticals USA, Inc. has initiated a voluntary Class II recall of Metoprolol Succinate Extended-Release Tablets, 50 mg. The recall was triggered after the product failed to meet dissolution specifications during testing. This failure indicates the medication may not release the active ingredient at the required rate.
Which Products Are Affected
The recall affects 67,043 bottles distributed nationwide across the United States. The specific products include:
- Product Name: Metoprolol Succinate Extended-Release Tablets, 50 mg
- Packaging: 100-tablet bottles (NDC: 45963-676-11) and 1,000-tablet bottles (NDC: 45963-676-96)
- Lot Numbers: 0486G251, 0487G251, 0488G251, 0486G252, 0487G253, and 0488G252
- Expiration Date: 01/2027
- Manufacturer: Actavis Pharma, Inc.
What You Should Do
Consumers who possess the affected lots should contact their healthcare provider or pharmacist to discuss alternative treatments. The firm initiated the recall process by sending notification letters to distributors and customers on January 29, 2026. For further inquiries, the recalling firm, Teva Pharmaceuticals USA, Inc., is located at 400 Interpace Pkwy Bldg A, Parsippany, NJ 07054.
Why This Matters
When an extended-release medication fails dissolution specifications, it may not provide the intended therapeutic effect or could potentially release the drug too quickly, which is a significant concern for patients managing cardiovascular conditions.
Source
Information provided by the FDA under Recall Number D-0355-2026.
Source: FDA Official Notice