Levofloxacin Tablets Recalled for Embossing and Packaging Insert Mismatch
Macleods Pharma USA recalls Levofloxacin Tablets 500 mg due to mismatched embossing on tablets versus the package insert labeling. The distributed bottles do not match the documented tablet markings.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III designation indicates a lower-risk recall. No illnesses, injuries, or deaths are reported. The issue is a minor labeling error—a documentation mismatch between tablet embossing and package insert labeling.
Plain-English summary
Macleods Pharma USA, Inc. is recalling Levofloxacin Tablets, USP 500 mg distributed in 50-count bottles. The product is identified with NDC 33342-022-08 and manufactured by Macleods Pharmaceuticals Ltd. in India. Lot #BLF2214A with an expiration date of June 2025 is affected.
The recall was issued due to a mismatch between the embossing on the tablets (marked T7) and the embossing referenced in the package insert (ML63). This discrepancy affects the labeling and identification information provided to users.
The affected product was distributed nationwide within the United States and Puerto Rico. A total of 10,052 bottles were distributed under this lot number.
The recalled product
- Product
- 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
- Manufacturer
- MACLEODS PHARMA USA, INC
- Category
- Drug
- Hazard
- Affected units
- 10,052
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: BLF2214A
- Exp. 06/2025
Distribution
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