CLASS II Drug recall · Reported 4 Jun 2014 · FDA Enforcement Report
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg recalled
Wockhardt Usa is recalling Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, distributed nationwide in the US. The recall was initiated on 10 Apr 2014 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-1355-2014
- FDA event ID
- 68402
- Recalling firm
- Wockhardt Usa, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Apr 2014
- FDA classified
- 29 May 2014
- Reported
- 4 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 10 Apr 2014 | Recall initiated by company | |
| 29 May 2014 | Classified by FDA | +49 days |
| 4 Jun 2014 | Published in enforcement report | +6 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: Failure of dissolution test observed at three month time point.
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, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Water view Blvd., Parsippany, NJ 07054, USA. NDC: 64679-736-02.
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: Failure of dissolution test observed at three month time point.
Which lots are affected?
Lot #: LN11423, Expiry: 8/15/15
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Wockhardt Usa
All 45| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Enalapril Maleate tablets, USP, 5mg recalled by Wockhardt Usa | Wockhardt Usa | Potency & Assay | Nationwide |
| Drug | CLASS II | Lisinopril Tablets USP, 20 mg recalled by Wockhardt Usa | Wockhardt Usa | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Lisinopril Tablets USP, 5 mg recalled by Wockhardt Usa | Wockhardt Usa | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Lisinopril Tablets recalled by Wockhardt Usa | Wockhardt Usa | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Famotodine Tablets, USP, For Repacking Only recalled by Wockhardt Usa | Wockhardt Usa | Manufacturing (CGMP) Deviations | Nationwide |
Other Metoprolol recalls
All 40| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* recalled | Ascend Laboratories | Potency & Assay | Nationwide |
| 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, 25 mg bottles 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 |