Food, drugs, devices › MACLEODS PHARMA USA, INC
Drug recall: Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 0
MACLEODS PHARMA USA, INC (Princeton, NJ) initiated this drug recall on 5 Jan 2023; FDA lists 1 product record under event 91441, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 26% of the 281 drug enforcement events initiated in 2023 carry the same class.
Status: Terminated, terminated 24 Jun 2025. Initiation: voluntary: firm initiated. MACLEODS PHARMA USA, INC has 21 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
MACLEODS PHARMA USA, INC, Princeton, NJ.
Reason for recall
"Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles."
Distribution
"Nationwide within United States and Puerto Rico."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 | 10052 bottles | Class III | Terminated | 25 Jan 2023 |
Context
Other enforcement events for MACLEODS PHARMA USA, INC
All 21 events for MACLEODS PHARMA USA, INC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide within United States and Puerto Rico."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 24 Jun 2025. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.