CLASS II Drug recall · Reported 25 Aug 2021 · FDA Enforcement Report
Carvedilol Tablets, USP 25 mg recalled by Zydus Pharmaceuticals (USA)
Zydus Pharmaceuticals is recalling Carvedilol Tablets, USP 25 mg, distributed nationwide in the US. The recall was initiated on 13 Aug 2021 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-0753-2021
- FDA event ID
- 88482
- Recalling firm
- Zydus Pharmaceuticals, Pennington, NJ
- Brand
- Carvedilol
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Aug 2021
- FDA classified
- 19 Aug 2021
- Reported
- 25 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Blood Pressure Medication
Timeline
| 13 Aug 2021 | Recall initiated by company | |
| 19 Aug 2021 | Classified by FDA | +6 days |
| 25 Aug 2021 | 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
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
Product as listed by the FDA
Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
Which lots are affected?
Z006279, exp 12/31/2022
Where was it sold?
Nationwide in the US
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 Zydus Pharmaceuticals
All 54| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 250 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 500 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl | Zydus Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Icosapent Ethyl capsules recalled by Zydus Pharmaceuticals (USA) | Zydus 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 |