CLASS II Drug recall · Reported 12 Feb 2014 · FDA Enforcement Report
Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg recalled
Dr. Reddy's Laboratories is recalling Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg, distributed in Louisiana, Michigan, Missouri, Mississippi, Ohio. The recall was initiated on 13 Dec 2013 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-1080-2014
- FDA event ID
- 67293
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Brand
- Metoprolol Succinate
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Dec 2013
- FDA classified
- 6 Feb 2014
- Reported
- 12 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 13 Dec 2013 | Recall initiated by company | |
| 6 Feb 2014 | Classified by FDA | +55 days |
| 12 Feb 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 Specification; 12-Month stability interval.
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
Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg 100 tablets Rx Only Mfd. By: Dr. Reddy's Laboratories Limited Bachepalli -500 090 INDIA NDC 55111-467-01
Where it was distributed
LA, MI, MO, MS & OH
Questions about this recall
Why was it recalled?
Failed Dissolution Specification; 12-Month stability interval.
Which lots are affected?
Lot # C207420 and C207416
Where was it sold?
LA, MI, MO, MS & OH
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 Dr. Reddy's Laboratories
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | 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 |