FDA Recall D-0312-2024
Dr. Reddy's Laboratories, Inc. · Princeton, NJ
Class III Ongoing 847 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
Product
Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-01
Reason for recall
Misprint on tablet
Recall record
- Recall number
D-0312-2024- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2024-01-18
- Classified by FDA Center
- 2024-02-06
- FDA published
- 2024-02-14
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Firm location
- Princeton, NJ
Drug identification
- Brand name(s)
- GLIMEPIRIDE
- Generic name(s)
- GLIMEPIRIDE
- Manufacturer(s)
- Dr. Reddy's Laboratories Limited
- NDC(s)
55111-320, 55111-321, 55111-322- Route(s)
- ORAL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.