Medications & Supplements/Prescription Drugs

Dr. Reddy's Tacrolimus Capsules Recalled for Incorrect Dosage Strength

Agency Publication Date: January 5, 2024

Summary

Dr. Reddy's Laboratories, Inc. is voluntarily recalling 8,280 bottles of Tacrolimus Capsules, USP 1mg, which is a medication used to prevent organ rejection after a transplant. The recall was initiated after a single 0.5 mg capsule was discovered inside a bottle labeled as 1 mg strength. This dosage error could lead to patients receiving less medication than prescribed, though no incidents or injuries have been reported to date.

Risk

Taking a lower dose of Tacrolimus than prescribed could result in sub-therapeutic blood levels, potentially leading to organ transplant rejection or other serious health complications. This medication is critical for maintaining the health of transplant recipients.

What You Should Do

This recall affects Tacrolimus Capsules, USP 1mg, sold in 100-count bottles under NDC 55111-526-01, specifically identifying with lot number C2307275 and an expiration date of January 2026.
Check the label on your prescription bottle for the NDC code 55111-526-01 and the lot number C2307275 to determine if your medication is part of the recall.
If you have health concerns or believe you have taken an incorrect dose, contact your healthcare provider or pharmacist immediately. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Tacrolimus Capsules, USP 1mg (100-Count Bottle)

Variants: 1mg, 100-Count Bottle

Lot Numbers:

C2307275 (Exp. January 2026)

NDC:

55111-526-01

Recall initiated due to one 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93622

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 8,280 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Tacrolimus Capsules, USP 1mg, sold in 100-count bottles under NDC 55111-526-01, specifically identifying with lot number C2307275 and an expiration date of January 2026.

Check the label on your prescription bottle for the NDC code 55111-526-01 and the lot number C2307275 to determine if your medication is part of the recall.

If you have health concerns or believe you have taken an incorrect dose, contact your healthcare provider or pharmacist immediately. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.