CLASS III Drug recall · Reported 15 Mar 2017 · FDA Enforcement Report
Levofloxacin Ophthalmic Solution, 5%, Sterile recalled by Actavis
Actavis is recalling Levofloxacin Ophthalmic Solution, 5%, Sterile, distributed nationwide in the US. The recall was initiated on 7 Feb 2017 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-0514-2017
- FDA event ID
- 76421
- Recalling firm
- Actavis, Parsippany, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Feb 2017
- FDA classified
- 9 Mar 2017
- Reported
- 15 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Antibiotics
Timeline
| 7 Feb 2017 | Recall initiated by company | |
| 9 Mar 2017 | Classified by FDA | +30 days |
| 15 Mar 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11707, NDC 50383-283-05
Where it was distributed
Nationwide
Questions about this recall
Is Levofloxacin Ophthalmic Solution, 5%, Sterile recalled?
Yes. Actavis recalled Levofloxacin Ophthalmic Solution, 5%, Sterile on 7 Feb 2017. The recall is Class III and its status is Terminated. Recall number D-0514-2017.
Why was it recalled?
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Which lots are affected?
Lot # 348748, Exp 11/30/2017; 350578, Exp 3/31/2018; 633467, Exp 3/31/2017
Where was it sold?
Nationwide
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.
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Other Levofloxacin ophthalmic recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levofloxacin Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Levofloxacin Ophthalmic Solution recalled by Akorn | Akorn | Manufacturing (CGMP) Deviations | Nationwide |