Acetazolamide tablets recalled for discoloration across US distribution
Rubicon Research Private Limited is recalling 3,984 bottles of Acetazolamide 125 mg tablets nationally due to discoloration. Affected lot is 30575HF1 with expiration November 2026.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall for a cosmetic defect (discoloration) with no reported safety issues, illnesses, or injuries. According to the rubric, Class III recalls are typically scored 1 or 2, and the cosmetic nature of the defect warrants a score of 1.
Plain-English summary
Rubicon Research Private Limited, a pharmaceutical manufacturer based in Thane, India, is recalling Acetazolamide Tablets, USP 125 mg across the United States due to discoloration of the product. Acetazolamide is a prescription medication used to treat various conditions.
The recall affects approximately 3,984 bottles distributed nationwide. The affected medication has lot number 30575HF1 with an expiration date of November 2026 and NDC 72888-047-01. The product was distributed by Advagen Pharma Limited in Plainsboro, New Jersey.
Consumers who have this medication should contact their healthcare provider or pharmacist for guidance. The medication should not be used until it can be verified that the patient's supply is not from the recalled lot. This is a voluntary recall initiated by the manufacturer on August 24, 2024.
The recalled product
- Product
- ACETAZOLAMIDE (ACETAZOLAMIDE)
- Brand
- ACETAZOLAMIDE
- Manufacturer
- Rubicon Research Private Limited
- Category
- Drug — Prescription Oral Tablet
- Hazard
- Affected units
- 3,984
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # 30575HF1
- exp. date
- Nov 2026 NDC# 72888-047-01
UPCs (2)
- 0372888047010
- 0372888048017
Distribution
Distributed nationwide across the United States.
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