Medications & Supplements/Prescription Drugs

Macleods Levofloxacin Tablets Recalled for Tablet Embossing Mismatch

Agency Publication Date: January 17, 2023

Summary

Macleods Pharma USA, Inc. is recalling 10,052 bottles of Levofloxacin (levofloxacin) Tablets, USP 500 mg, because the physical markings on the tablets do not match the description provided in the package insert. The tablets in the bottle are embossed with "T7," but the accompanying instructions incorrectly state the tablets are marked with "ML63." No injuries or incidents have been reported in connection with this error.

Risk

The mismatch between the tablet marking and the printed instructions could cause confusion for patients or healthcare providers when trying to identify the medication. There is no report of the drug itself being contaminated or incorrect in strength.

What You Should Do

The recalled product is Levofloxacin Tablets, USP 500 mg, sold in 50-count bottles under NDC 33342-022-08, specifically from lot BLF2214A with an expiration date of June 2025.
Check your medication to see if the tablets are marked with "T7" while the package insert describes them as "ML63"; if this mismatch exists, the product is part of the recall.
If you have health concerns, contact your healthcare provider or pharmacist. 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) 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: Levofloxacin Tablets, USP 500 mg (50-count bottle)

Variants: 500 mg, Tablet

Lot Numbers:

BLF2214A (Exp. 06/2025)

NDC:

33342-022-08

Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63).

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91441

Status: Resolved

Manufacturer: MACLEODS PHARMA USA, INC

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 10052 bottles

Distributed To: Nationwide

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

The recalled product is Levofloxacin Tablets, USP 500 mg, sold in 50-count bottles under NDC 33342-022-08, specifically from lot BLF2214A with an expiration date of June 2025.

Check your medication to see if the tablets are marked with "T7" while the package insert describes them as "ML63"; if this mismatch exists, the product is part of the recall.

If you have health concerns, contact your healthcare provider or pharmacist. 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) for additional questions.