CLASS II Drug recall · Reported 27 Aug 2014 · FDA Enforcement Report
Wockhardt Metoprolol Succinate Extended-Release Tablets recalled
Wockhardt Usa is recalling Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) bottle (, distributed nationwide in the US. The recall was initiated on 24 Jul 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-1541-2014
- FDA event ID
- 68941
- Recalling firm
- Wockhardt Usa, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jul 2014
- FDA classified
- 18 Aug 2014
- Reported
- 27 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 24 Jul 2014 | Recall initiated by company | |
| 18 Aug 2014 | Classified by FDA | +25 days |
| 27 Aug 2014 | Published in enforcement report | +9 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: Dissolution failures found during testing of control samples at the four hour 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
Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ 07054 USA
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.
Which lots are affected?
Lot # a) LN11005, Exp 04/15; LN11006; Exp 04/15; b) LN10979; Exp. 04/15, LN10980; Exp. 04/15
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.
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|---|---|---|---|---|---|
| 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 Wockhardt Metoprolol recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Wockhardt Metoprolol Succinate recalled | Wockhardt Usa | Potency & Assay | Nationwide |