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Unrated Drug recall · FDA · Published June 17, 2019

Bausch & Lomb Lotemax Ophthalmic Gel Recall: Failed Stability Specifications

Bausch & Lomb recalls Lotemax (0.5% loteprednol etabonate ophthalmic gel) due to failed stability specifications. Affected lots expire 10/2019 or 11/2019. Contact for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1396-2019DrugBausch & Lomb ›
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Contact the company

Recalling firmBausch & Lomb8500 Hidden River Pkwy · Tampa, FL 33637-1014
✎ GovInfoNow plain-language explainer

Bausch & Lomb is recalling Lotemax ophthalmic gel because it failed stability tests, meaning it may not be safe for use. This recall affects specific lots that expired by October 2019 or November 2019. If you have the recalled product, you should contact the manufacturer for instructions. Read more at govinfonow.com/recall/38635-bausch-lomb-lotemax-ophthalmic-gel-recall-failed-stability-specifications.

Source Summary by GovInfoNow · govinfonow.com/recall/38635-bausch-lomb-lotemax-ophthalmic-gel-recall-failed-stability-specifications · Updated October 5, 2026 · FDA enforcement record: FDA #D-1396-2019

Cite this page

“Bausch & Lomb Lotemax Ophthalmic Gel Recall: Failed Stability Specifications.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38635-bausch-lomb-lotemax-ophthalmic-gel-recall-failed-stability-specifications. Based on FDA recall #D-1396-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1396-2019%22&limit=1).

Bausch & Lomb voluntarily recalled Lotemax ophthalmic gel due to failed stability specifications for viscosity, according to the FDA on June 17, 2019.

How to tell if you have it

  • Brand: Bausch & Lomb
  • Product: Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box
  • NDC: 24208-503-07
  • Lot codes: 282611, 283431, 283441, 283451 (Exp. 10/2019); 282971, 282981, 283611, 283621, 283631 (Exp. 11/2019)
  • Quantity: 170,832 bottles
  • Distribution: Nationwide in the U.S.

The hazard

The product failed stability specifications for viscosity, according to the FDA.

Context

GovInfoNow's records show other recent recalls of similar products include Sun Pharmaceutical Diclofenac Gel Recall (2026-01-27) and Kirkman MAXIMUM Lidocaine Cream Recall (2026-02-18). Safecor Health Fluphenazine Elixir Recall occurred on 2026-08-13.

How to tell if you have this one

Check the lot number on the box: 282611, 283431, 283441, 283451 (expiring 10/2019) or 282971, 282981, 283611, 283621, 283631 (expiring 11/2019). The product is a prescription-only ophthalmic gel sold in 5g boxes.

  • Brand
    Bausch & Lomb
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Lot Number

    Look for the lot numbers listed in the recall: 282611, 283431, 283441, 283451 (expiring 10/2019) or 282971, 282981, 283611, 283621, 283631 (expiring 11/2019).

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide in the U.S.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.3 years after the firm started it.

1. Firm started the recall: Jun 17, 201912. FDA classified it Class III: Jun 19, 201923. Published in FDA’s Enforcement Report: Jun 19, 201934. FDA terminated the recall: Sep 24, 2021420192021
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-1396-2019 (June 17, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1396-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA