CLASS II Drug recall · Reported 6 Feb 2013 · FDA Enforcement Report
Carvedilol Tablets recalled by Mylan Pharmaceuticals
Mylan Pharmaceuticals is recalling Carvedilol Tablets, USP, 12, distributed nationwide in the US. The recall was initiated on 16 Jan 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-137-2013
- FDA event ID
- 64154
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jan 2013
- FDA classified
- 28 Jan 2013
- Reported
- 6 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Blood Pressure Medication
Timeline
| 16 Jan 2013 | Recall initiated by company | |
| 28 Jan 2013 | Classified by FDA | +12 days |
| 6 Feb 2013 | 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 Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
Product as listed by the FDA
Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-3633-05, UPC 3 0378-3633-05 3.
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
Which lots are affected?
Lot #: ZCMH12031, ZCMH12032, ZCMH12033, ZCMH12034, Exp 02/14
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 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 Mylan Pharmaceuticals
All 84| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Acamprosate Calcium, Delayed-Release Tablets, 333 mg recalledAcamprosate Calcium | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
Other Carvedilol recalls
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carvedilol Tablets USP, 12.5 mg recalled by The Harvard Drug GroupCarvedilol | The Harvard Drug Group | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Carvedilol Tablets, USP, 25 mg recalled by Glenmark PharmaceuticalsCarvedilol | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Carvedilol Tablets, USP, 3.125 mg, Packaged as: a) recalledCarvedilol | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Carvedilol Tablets, USP, 12.5 mg recalled by Glenmark PharmaceuticalsCarvedilol | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Carvedilol Tablets, USP, 25 mg recalled by Glenmark PharmaceuticalsCarvedilol | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |