Lower risk Drug recall · FDA · Published February 24, 2025

Imprimis Ophthalmic Solution Recall: Subpotent Drug Risk

Imprimis recalls ophthalmic solution with subpotent drug levels. Product may not work as intended. Check NDC 71384-733-05 and lot 24OCT041 for affected items.

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

🇺🇸 FDA recall #D-0305-2025Drug Imprimis ›

Lower-risk recall

Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.

Take action

Contact the company

Recalling firmImprimis NJOF, LLC1705 Route 46 Ste 6B · Ledgewood, NJ 07852-9720

✎ GovInfoNow plain-language explainer

Imprimis recalls a specific ophthalmic solution due to unstable drug levels that may not work as intended. This affects users who need the medication for eye conditions. Read more at govinfonow.com/recall/32268-imprimis-ophthalmic-solution-recall-subpotent-drug-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/32268-imprimis-ophthalmic-solution-recall-subpotent-drug-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0305-2025

Cite this page

“Imprimis Ophthalmic Solution Recall: Subpotent Drug Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32268-imprimis-ophthalmic-solution-recall-subpotent-drug-risk. Based on FDA recall #D-0305-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0305-2025%22&limit=1).

Imprimis NJOF, LLC recalled Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution due to sub-potent drug risks, the FDA announced on Feb. 24, 2025.

How to tell if you have it

Brand: Imprimis
Product: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle
NDC: 71384-733-05
Lot: 24OCT041
Expiration: 04/26/2025
Distribution: FL and NY

The hazard

The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.

Context

Imprimis NJOF, LLC has 13 other recalls on record since 2020-12-17. Other recent recalls include Imprimis Tri-Moxi+ Intraocular Injection Recall (2025-12-18), Klarity-C Drops Recall (2025-10-20), and Imprimis Epinephrine Vials Recall (2025-07-09). Other recent recalls of similar products include ImprimisRx Povidone Iodine Ophthalmic Solution Recall (2026-08-24) and SUN PHARMACEUTICAL Clindamycin Phosphate Topical Solution Recall (2025-11-26).

How to tell if you have this one

Check for the NDC code 71384-733-05 on the bottle. The lot number 24OCT041 and expiration date 04/26/2025 are also on the label.

Brand
Imprimis
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the NDC code 71384-733-05 and lot number 24OCT041 on the bottle label.

Where it went and when

Where it was distributed

Distributed in Florida and New York.

FDA distribution: “FL and NY” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, New York.

Recall timeline

FDA published this recall 44 days after the firm started it.

Feb 24, 2025Firm started the recall
Mar 28, 2025FDA classified it Class III
Apr 9, 2025Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/32268-imprimis-ophthalmic-solution-recall-subpotent-drug-risk">Imprimis Ophthalmic Solution Recall: Subpotent Drug Risk (GovInfoNow)</a>

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-0305-2025 (February 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0305-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.