CLASS III Drug recall · Reported 16 Aug 2023 · FDA Enforcement Report
Dofetilide Capsules 500 mcg (0.5mg) recalled
SUN Pharmaceutical Industries is recalling Dofetilide Capsules 500 mcg (0.5mg), distributed nationwide in the US. The recall was initiated on 18 Jul 2023 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-1082-2023
- FDA event ID
- 92725
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Brand
- Dofetilide
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Jul 2023
- FDA classified
- 7 Aug 2023
- Reported
- 16 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 18 Jul 2023 | Recall initiated by company | |
| 7 Aug 2023 | Classified by FDA | +20 days |
| 16 Aug 2023 | 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
Out of Specification result observed in content uniformity testing
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
Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T of D & NH), India, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512. NDC 47335-063-86
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Out of Specification result observed in content uniformity testing
Which lots are affected?
Lot: DNE0217A, Exp 01/2025
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 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 SUN Pharmaceutical Industries
All 138| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Perampanel CIII Tablets, 6mg recalled by Sun Pharmaceutical IndustriesPerampanel | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |
| Drug | CLASS I | DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension, 1mg recalledBudesonide | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
Other Dofetilide recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Dofetilide Capsules, 500 mcg (0.5 mg) recalled | SUN Pharmaceutical Industries | Other | Nationwide |
| Drug | CLASS II | Dofetilide Capsules, 125 mcg (0.125 mg) recalled by Accord HealthcareDofetilide | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |
| Drug | CLASS II | Dofetilide Capsules 500 mcg (0.5 mg) recalled by Accord HealthcareDofetilide | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |
| Drug | CLASS II | Dofetilide Capsules 250 mcg (0.25 mg) recalled by Accord HealthcareDofetilide | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |
| Drug | CLASS II | Tikosyn (dofetilide) 125 mcg (0.125 mg), a) bottle recalled by PfizerTikosyn | Pfizer | Other | NY |