CLASS II ONGOING Drug recall · Reported 11 Mar 2026 · FDA Enforcement Report
Metoprolol Succinate Extended-Release Tablets, 25 mg bottles recalled
Teva Pharmaceuticals USA is recalling Metoprolol Succinate Extended-Release Tablets, 25 mg bottles (, distributed nationwide in the US. The recall was initiated on 29 Jan 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0354-2026
- FDA event ID
- 98348
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Brand
- Metoprolol Succinate
- Manufacturer
- Actavis Pharma, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Jan 2026
- FDA classified
- 27 Feb 2026
- Reported
- 11 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 29 Jan 2026 | Recall initiated by company | |
| 27 Feb 2026 | Classified by FDA | +29 days |
| 11 Mar 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Is Metoprolol Succinate Extended-Release Tablets, 25 mg bottles ( recalled?
Yes. Teva Pharmaceuticals USA recalled Metoprolol Succinate Extended-Release Tablets, 25 mg bottles ( on 29 Jan 2026. The recall is Class II and its status is Ongoing. Recall number D-0354-2026.
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
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.
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Metoprolol recalls
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets recalledMetoprolol Succinate | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, 200 mg recalledMetoprolol Succinate | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, 50 mg bottles recalledMetoprolol Succinate | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Tartrate Tablets, USP, 50 mg recalled | Westminster Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Metoprolol Tartrate Tablets, USP, 100 mg recalled | Westminster Pharmaceuticals | Nitrosamine Impurity | Nationwide |