CLASS II Drug recall · Reported 15 May 2019 · FDA Enforcement Report
Carvedilol Tablets, USP, 6.25 mg recalled by Zydus Pharmaceuticals USA
Zydus Pharmaceuticals USA is recalling Carvedilol Tablets, USP, 6.25 mg, distributed nationwide in the US. The recall was initiated on 25 Apr 2019 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-1273-2019
- FDA event ID
- 82714
- Recalling firm
- Zydus Pharmaceuticals USA, Pennington, NJ
- Brand
- Carvedilol
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Apr 2019
- FDA classified
- 7 May 2019
- Reported
- 15 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Blood Pressure Medication
Timeline
| 25 Apr 2019 | Recall initiated by company | |
| 7 May 2019 | Classified by FDA | +12 days |
| 15 May 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-093-05
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Which lots are affected?
Z804517, exp Nov 30, 2020
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.
Other products in this recall event
1 other product · FDA event 82714This product is part of a recall event; the main page for the event is Acyclovir Tablets, USP, 400 mg recalled by Zydus Pharmaceuticals USA.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Acyclovir Tablets, USP, 400 mg recalled by Zydus Pharmaceuticals USAAcyclovir | Zydus Pharmaceuticals USA | Packaging Defects | Nationwide |
More recalls from Zydus Pharmaceuticals USA
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 1 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | MethylPREDNISolone Tablets, USP 32 mg recalledMethylprednisolone | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 0.25 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 0.125 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | 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 |