Recalls / Class II
Class IID-0219-2024
Product
Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01
- Brand name
- Tacrolimus
- Generic name
- Tacrolimus
- Active ingredient
- Tacrolimus
- Route
- Oral
- NDCs
- 55111-525, 55111-526, 55111-527
- FDA application
- ANDA090509
- Affected lot / code info
- Lot# C2307275; Exp. January 2026
Why it was recalled
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
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
- 8,280 bottles
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2023-12-15
- FDA classified
- 2024-01-05
- Posted by FDA
- 2024-01-17
- Terminated
- 2024-09-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0219-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.