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Lower risk Drug recall · FDA · Published August 10, 2023

Imprimis Moxifloxacin-Bromfenac Eye Drops Recall: Subpotent Drug Risk

Imprimis recalls 5mL eye drop bottles with subpotent Bromfenac levels. These drops may not provide proper treatment for eye infections. Stop using immediately if you have the affected lot numbers.

🇺🇸 FDA recall #D-1094-2023DrugImprimis ›
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Recalling firmImprimis NJOF, LLC1705 Route 46 Ste 6B · Ledgewood, NJ 07852-9720
✎ GovInfoNow plain-language explainer

Imprimis is recalling certain eye drops that contain less than the required amount of Bromfenac. This could lead to ineffective treatment for eye infections. Consumers should stop using these products and contact the manufacturer for details. Read more at govinfonow.com/recall/33216-imprimis-moxifloxacin-bromfenac-eye-drops-recall-subpotent-drug-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/33216-imprimis-moxifloxacin-bromfenac-eye-drops-recall-subpotent-drug-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-1094-2023

Cite this page

“Imprimis Moxifloxacin-Bromfenac Eye Drops Recall: Subpotent Drug Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/33216-imprimis-moxifloxacin-bromfenac-eye-drops-recall-subpotent-drug-risk. Based on FDA recall #D-1094-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1094-2023%22&limit=1).

Imprimis NJOF, LLC voluntarily recalled Moxifloxacin - Bromfenac Sterile Ophthalmic Solution due to subpotent drug levels below specification, according to the FDA on August 10, 2023.

How to tell if you have it

  • Brand: Imprimis
  • Product: Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle
  • NDC: 71384-311-05
  • Lot #s: 22DEC047 exp 9/16/23, 23FEB057 exp 11/24/23

The hazard

The recall addresses subpotent drug levels, specifically Bromfenac concentrations falling below the 90.0-110.0% specification range.

Context

GovInfoNow's records show Imprimis NJOF, LLC has 13 other recalls on record since December 17, 2020. Other recent recalls of similar products include Imprimis Rx Povidone Iodine Ophthalmic Solution Recall (August 24, 2026), Apotex Brimonidine/Timolol Eye Drops Recall (March 5, 2026), and K.C. Pharmaceuticals Sterile Eye Drops AC Recall (March 3, 2026).

How to tell if you have this one

Check for the 5mL bottle labeled with the product name Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 0.5%/0.075%. Look for the lot numbers 22DEC047 (expires 9/16/23) or 23FEB057 (expires 11/24/23).

  • Brand
    Imprimis
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Immediately

    Discard the affected eye drops if you have the lot numbers 22DEC047 or 23FEB057.

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 US” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 5 months after the firm started it.

1. Firm started the recall: Aug 10, 202312. FDA classified it Class III: Aug 21, 202323. Published in FDA’s Enforcement Report: Aug 30, 202334. FDA terminated the recall: Jan 22, 2024420232024
  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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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-1094-2023 (August 10, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1094-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on September 23, 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