CLASS III Drug recall · Reported 24 Dec 2014 · FDA Enforcement Report
Wockhardt Metoprolol Succinate recalled
Wockhardt Usa is recalling Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a) HDPE bottle (, distributed nationwide in the US. The recall was initiated on 17 Apr 2014 and the FDA has classified it as Class III.
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-0304-2015
- FDA event ID
- 69506
- Recalling firm
- Wockhardt Usa, Parsippany, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Apr 2014
- FDA classified
- 18 Dec 2014
- Reported
- 24 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 17 Apr 2014 | Recall initiated by company | |
| 18 Dec 2014 | Classified by FDA | +245 days |
| 24 Dec 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: Product was out of specification (OOS) at the 12 month long term stability testing 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, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA .
Where it was distributed
Nationwide.
Questions about this recall
Is Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a) HDPE bottle ( recalled?
Yes. Wockhardt Usa recalled Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a) HDPE bottle ( on 17 Apr 2014. The recall is Class III and its status is Terminated. Recall number D-0304-2015.
Why was it recalled?
Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
Which lots are affected?
a) Lot # LN10392; Exp. 12/14 b) Lot # LN10360; Exp. 12/14
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Wockhardt Usa
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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 |
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| Drug | CLASS II | Famotodine Tablets, USP, For Repacking Only recalled by Wockhardt Usa | Wockhardt Usa | Manufacturing (CGMP) Deviations | Nationwide |