CLASS II Drug recall · Reported 23 Nov 2022 · FDA Enforcement Report
Carvedilol Tablets, USP, 25 mg recalled by Viatris
Viatris is recalling Carvedilol Tablets, USP, 25 mg, distributed nationwide in the US. The recall was initiated on 21 Oct 2022 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-0063-2023
- FDA event ID
- 91038
- Recalling firm
- Viatris, Canonsburg, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Oct 2022
- FDA classified
- 16 Nov 2022
- Reported
- 23 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Blood Pressure Medication
Timeline
| 21 Oct 2022 | Recall initiated by company | |
| 16 Nov 2022 | Classified by FDA | +26 days |
| 23 Nov 2022 | Published in enforcement report | +7 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: Tablets exceeds specification for weight and thickness.
Product as listed by the FDA
Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
Which lots are affected?
Lot #: 3150116, Exp 2/2025
Where was it sold?
Nationwide in the USA
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 II | Levothyroxine Sodium Tablets USP, 25 mcg recalled by ViatrisLevothyroxine Sodium | Viatris | Potency & Assay | Nationwide |
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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 |