CLASS II Drug recall · Reported 3 Feb 2016 · FDA Enforcement Report
Levofloxacin Tablets USP, 500 mg recalled by Amerisource Health Services
Amerisource Health Services is recalling Levofloxacin Tablets USP, 500 mg, distributed nationwide in the US. The recall was initiated on 18 Jan 2016 and the FDA has classified it as Class II.
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-0610-2016
- FDA event ID
- 73094
- Recalling firm
- Amerisource Health Services, Columbus, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jan 2016
- FDA classified
- 27 Jan 2016
- Reported
- 3 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 18 Jan 2016 | Recall initiated by company | |
| 27 Jan 2016 | Classified by FDA | +9 days |
| 3 Feb 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister cards per carton, individual blisters labeled UPC (01) 003 68084 482 11 3, carton labeled NDC 68084-482-01, UPC (01) 0 03 68084 482 01 4; Rx only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
Which lots are affected?
Lot # 151387, Exp 10/31/16
Where was it sold?
Nationwide 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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 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 Amerisource Health Services
All 69| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Primidone Tablets, USP, 250 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) [] recalledMeclizine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride, Capsules, USP, 1 mg recalledPrazosin Hydrochloride | Amerisource Health Services | Nitrosamine Impurity | Nationwide |
Other Levofloxacin recalls
All 19| 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 Ophthalmic Solution 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 III | Levofloxacin Tablets, USP 500 mg recalled by Macleods Pharma Usa | Macleods Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Levofloxacin Tablets, 500 mg unit dose recalledLevofloxacin | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |