CLASS III Drug recall · Reported 25 Jan 2023 · FDA Enforcement Report
Levofloxacin Tablets, USP 500 mg recalled by Macleods Pharma Usa
Macleods Pharma Usa is recalling Levofloxacin Tablets, USP 500 mg, distributed nationwide in the US. The recall was initiated on 5 Jan 2023 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0162-2023
- FDA event ID
- 91441
- Recalling firm
- Macleods Pharma Usa, Princeton, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Jan 2023
- FDA classified
- 17 Jan 2023
- Reported
- 25 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Antibiotics
Timeline
| 5 Jan 2023 | Recall initiated by company | |
| 17 Jan 2023 | Classified by FDA | +12 days |
| 25 Jan 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide within United States and Puerto Rico.
Questions about this recall
Is Levofloxacin Tablets, USP 500 mg recalled?
Yes. Macleods Pharma Usa recalled Levofloxacin Tablets, USP 500 mg on 5 Jan 2023. The recall is Class III and its status is Terminated. Recall number D-0162-2023.
Why was it recalled?
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Which lots are affected?
Lot #: BLF2214A; Exp. 06/2025
Where was it sold?
Nationwide within United States and Puerto Rico.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Macleods Pharma Usa
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|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets USP 150 mcg recalled by Macleods Pharma UsaLevothyroxine Sodium | Macleods Pharma Usa | Potency & Assay | Nationwide |
| Drug | CLASS II | Losartan Potassium and Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma Usa | Foreign Material | Nationwide |
| Drug | CLASS II | Eszopiclone Tablets, USP 1 mg recalled by Macleods Pharma UsaEszopiclone | Macleods Pharma Usa | Packaging Defects | Nationwide |
| Drug | CLASS II | Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma Usa | Potency & Assay | Nationwide |
| Drug | CLASS II | Losartan Potassium & Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma Usa | Potency & Assay | Nationwide |
Other Levofloxacin recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levofloxacin Oral Solution, 25 mg/mL recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Levofloxacin Injection 500mg/ (25 mg/mL), For Intravenous Infusion recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Levofloxacin Tablets, 500 mg unit dose recalledLevofloxacin | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Levofloxacin Injection in 5% Dextrose 500 mg in 5% Dextrose recalledLevofloxacin | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS III | Levofloxacin Injection in 5% Dextrose, 5 mg/mL recalledLevofloxacin | Baxter Healthcare | Potency & Assay | Nationwide |