Why it was recalled
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
Product description
Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01
Lot numbers, UPCs & expiration codes
Lot# C2307275; Exp. January 2026
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0219-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 15, 2023
- FDA report date
- Jan 17, 2024
- Quantity
- 8,280 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0219-2024, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 93622
- Address
- 107 College Rd E
- Code information
- Lot# C2307275; Exp. January 2026
- Postal code
- 08540-6623
- Report date
- Jan 17, 2024
- Product type
- Drugs
- Recall number
- D-0219-2024
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 8,280 bottles
- Termination date
- Sep 16, 2024
- Reason for recall
- Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Dec 15, 2023
- Initial firm notification
- Letter
- Center classification date
- Jan 5, 2024