Teva Pharmaceuticals Recalls Metoprolol Succinate Extended-Release Tablets Due to Dissolution Failure
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Teva Pharmaceuticals USA, Inc. has voluntarily recalled over 67,000 bottles of Metoprolol Succinate Extended-Release Tablets after the medication failed dissolution specifications.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 2, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, drugs.
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.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.