FDA Drug · D-0162-2023

Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540; Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-022-08

Class III · Terminated

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

Affected lots / codes — check yours against thisLot #: BLF2214A; Exp. 06/2025

Recalling firm: MACLEODS PHARMA USA, INC, Princeton, NJ
Classification: Class III (unlikely to cause harm)
Status: Terminated
Quantity: 10052 bottles
Distribution: Nationwide within United States and Puerto Rico.
Recall initiated: January 5, 2023
Classified: January 17, 2023
Terminated: June 24, 2025
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0162-2023%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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