AcetaZOLAMIDE Tablets recall
FDA recall D-0659-2024 · initiated Aug 24, 2024
Rubicon Research Private Limited recalled AcetaZOLAMIDE Tablets in Aug 2024 — an FDA Class III recall (D-0659-2024) because Discoloration.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Discoloration
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 3,984 bottles
Details
- Product
- 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
- Recalling company
- Rubicon Research Private Limited
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US
- Initiated
- Aug 24, 2024
- FDA report date
- Sep 25, 2024
Frequently asked
- Was AcetaZOLAMIDE Tablets recalled?
- Rubicon Research Private Limited recalled AcetaZOLAMIDE Tablets in Aug 2024 — an FDA Class III recall (D-0659-2024) because Discoloration. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was AcetaZOLAMIDE Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0659-2024 was: Discoloration
- Is a recalled AcetaZOLAMIDE Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of AcetaZOLAMIDE Tablets are affected?
- Distributed: Nationwide in the US. The recall covers these lots — Lot # 30575HF1, exp. date, Nov 2026 NDC# 72888-047-01. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0659-2024.