CLASS III Drug recall · Reported 19 Jun 2019 · FDA Enforcement Report
Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile recalled
Bausch & Lomb is recalling Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, distributed nationwide in the US. The recall was initiated on 17 Jun 2019 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-1396-2019
- FDA event ID
- 83093
- Recalling firm
- Bausch & Lomb, Tampa, FL
- Brand
- Lotemax
- Manufacturer
- Bausch & Lomb Incorporated
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Jun 2019
- FDA classified
- 19 Jun 2019
- Reported
- 19 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 17 Jun 2019 | Recall initiated by company | |
| 19 Jun 2019 | Classified by FDA | +2 days |
| 19 Jun 2019 | Published in enforcement report | +0 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: Out of specification for viscosity.
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
Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, NDC 24208-503-07.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
Failed Stability Specifications: Out of specification for viscosity.
Which lots are affected?
Lot #s: 282611; 283431; 283441; 283451, Exp. 10/2019; 282971; 282981; 283611; 283621; 283631, Exp. 11/2019.
Where was it sold?
Nationwide in the U.S.
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 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 Bausch & Lomb
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Bausch + Lomb Stellaris Elite Vision Enhancement System recalled | Bausch & Lomb | Packaging Defects | 26 states |
| Device | CLASS II | Bausch + Lomb Stellaris Elite Vision Enhancement System recalled | Bausch & Lomb | Packaging Defects | 26 states |
| Device | CLASS II | Bausch + Lomb Stellaris Elite Vision Enhancement System recalled | Bausch & Lomb | Packaging Defects | 26 states |
| Device | CLASS II | Bausch + Lomb Stellaris Elite Vit Cutter recalled | Bausch & Lomb | Packaging Defects | 26 states |
| Device | CLASS II | Bausch + Lomb Stellaris Elite Vision Enhancement System recalled | Bausch & Lomb | Packaging Defects | 26 states |
Other Loteprednol Etabonate recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%) recalledLoteprednol Etabonate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |