Class II — Moderate Risk Severity Status: Ongoing Authority: FDA

METOPROLOL SUCCINATE

Recalling Firm / Manufacturer: Teva Pharmaceuticals USA, Inc (Parsippany, NJ, United States)
FDA Recall Number: D-0354-2026
View FDA Source
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
METOPROLOL SUCCINATE
Generic Name
METOPROLOL SUCCINATE
Active Substance(s)
Metoprolol Succinate
Administration Route
Oral
National Drug Code (NDC)
45963-676
Total Quantity Recalled
18,780 bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA

According to the official FDA enforcement report:

Failed Dissolution Specifications

Full Product Description
Packaging specifications and labeling details

Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054

Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
March 11, 2026
Firm Initiation Date
January 29, 2026
FDA Classification Date
Feb 27, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot#: a) 0715J251, Exp.: 12/2026; 0716J251, Exp.: 01/2027; 0717J251, Exp.: 01/2027; b) 0715J252, Exp.: 12/2026; 0716J252, Exp.: 01/2027, 0717J252, Exp.: 01/2027.
Distribution Information
Geographic scope of affected shipments

Nationwide

Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.

Official Source Provenance

Verified regulatory citation from U.S. FDA OpenFDA

Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0354-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508606UTCC
View Official FDA Source

System Notice

Confirm Action