Recalls / Class III
Class IIID-0313-2024
Product
Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05
- Brand name
- Glimepiride
- Generic name
- Glimepiride
- Active ingredient
- Glimepiride
- Route
- Oral
- NDCs
- 55111-320, 55111-321, 55111-322
- FDA application
- ANDA077091
- Affected lot / code info
- Lot: T2303609; Exp. 06/2026 Lot: T2303610; Exp. 06/2026
Why it was recalled
Misprint on tablet
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 14,425 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2024-01-18
- FDA classified
- 2024-02-06
- Posted by FDA
- 2024-02-14
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0313-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.