CLASS III Drug recall · Reported 1 Dec 2021 · FDA Enforcement Report
Carvedilol Tablets, USP, 6.25 mg recalled by Aurobindo Pharma USA
Aurobindo Pharma USA is recalling Carvedilol Tablets, USP, 6.25 mg, distributed nationwide in the US. The recall was initiated on 15 Nov 2021 and the FDA has classified it as Class III.
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-0263-2022
- FDA event ID
- 89045
- Recalling firm
- Aurobindo Pharma USA, East Windsor, NJ
- Brand
- Carvedilol
- Manufacturer
- Aurobindo Pharma Limited
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Nov 2021
- FDA classified
- 1 Dec 2021
- Reported
- 1 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 15 Nov 2021 | Recall initiated by company | |
| 1 Dec 2021 | Classified by FDA | +16 days |
| 1 Dec 2021 | Published in enforcement report | +0 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications
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
Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, East Windsor, NJ, 08520, Made in India, NDC 65862-143-05
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Batch QG0619030-A, exp 11/2022
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Aurobindo Pharma USA
All 59| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dicyclomine Hydrochloride Capsules, USP, 10mg recalledDicyclomine Hydrochloride | Aurobindo Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nebivolol Tablets recalled by Aurobindo Pharma USANebivolol | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 90 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 30 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | 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 |