CLASS III ONGOING Drug recall · Reported 25 Sep 2024 · FDA Enforcement Report
AcetaZOLAMIDE Tablets, USP, 125 mg bottled recalled
Rubicon Research Private is recalling AcetaZOLAMIDE Tablets, USP, 125 mg bottled, distributed nationwide in the US. The recall was initiated on 24 Aug 2024 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-0659-2024
- FDA event ID
- 95217
- Recalling firm
- Rubicon Research Private, Ambarnath
- Brand
- Acetazolamide
- Manufacturer
- Advagen Pharma Ltd
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 24 Aug 2024
- FDA classified
- 13 Sep 2024
- Reported
- 25 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 24 Aug 2024 | Recall initiated by company | |
| 13 Sep 2024 | Classified by FDA | +20 days |
| 25 Sep 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discoloration
Product as listed by the FDA
AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Manufactured by Rubicon Research Private Limited, Thane, India NDC 72888-047-01
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
Discoloration
Which lots are affected?
Lot # 30575HF1, exp. date, Nov 2026 NDC# 72888-047-01
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 Rubicon Research Private
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metoprolol Tartrate Tablets USP, 25mg recalledMetoprolol Tartrate | Rubicon Research Private | Foreign Material | Nationwide |
| Drug | CLASS II | traMADol Hydrochloride Tablets, USP 50 mg recalledTramadol Hydrochloride | Rubicon Research Private | Other | Nationwide |
| Drug | CLASS II | Metoprolol Tartrate Tablets, USP 25 mg recalledMetoprolol Tartrate | Rubicon Research Private | Foreign Material | Nationwide |
Other Acetazolamide recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | AcetaZOLAMIDE Tablets, USP 125 mg recalled by Cardinal HealthAcetazolamide | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Acetazolamide, Lyophilized 500mg Injectable10 Vial, 4 Vial recalled | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Sterility | Nationwide |