Lower risk Drug recall · FDA · Published July 9, 2025

Imprimis Ophthalmic Solution Recall: Subpotent Drug Risk

Imprimis recalls specific ophthalmic solution due to subpotent drug levels. This may not work as intended for eye treatments. Check your product details to see if affected.

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

🇺🇸 FDA recall #D-0536-2025Drug Imprimis ›

Lower-risk recall

Sub-Potent Drug: Subpotent assay results during stability testing.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Imprimis is recalling a specific ophthalmic solution that may have lower-than-stated drug levels. This could mean the medication isn't effective for treating eye conditions. Affected users should check their product details and contact the manufacturer. Read more at govinfonow.com/recall/31987-imprimis-ophthalmic-solution-recall-subpotent-drug-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/31987-imprimis-ophthalmic-solution-recall-subpotent-drug-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0536-2025

Cite this page

“Imprimis Ophthalmic Solution Recall: Subpotent Drug Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31987-imprimis-ophthalmic-solution-recall-subpotent-drug-risk. Based on FDA recall #D-0536-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0536-2025%22&limit=1).

The FDA announced on July 9, 2025, that Imprimis NJOF, LLC is recalling Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution due to sub-potent drug risks. The recall involves 2,890 vials distributed nationwide.

How to tell if you have it

Brand: Imprimis
Product: Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton
NDC: 71384-733-05
Lot: 25MAR032
Expiration Date: 07/16/2025

The hazard

The product poses a sub-potent drug hazard because stability testing revealed subpotent assay results. The recall is classified as Class III.

Context

GovInfoNow's records show Imprimis NJOF, LLC has 13 other recalls on record since December 17, 2020. Recent brand recalls include the Imprimis Tri-Moxi+ Intraocular Injection Recall (December 18, 2025) and the Klarity-C Drops Recall (October 20, 2025). Other recent recalls of similar products include the ImprimisRx Povidone Iodine Ophthalmic Solution Recall (August 24, 2026) and the SUN PHARMACEUTICAL Clindamycin Phosphate Topical Solution Recall (November 26, 2025).

How to tell if you have this one

Check for the product name 'Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton' with NDC 71384-733-05 and lot number 25MAR032.

Brand
Imprimis
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Status
Completed
Distribution
Nationwide in the USA

Recall number	Product, codes & lots	Quantity	Class
D-0535-2025	Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01; Lot: 24DEC017, Exp. 07/12/2025.	6,880 vials	Class II
D-0536-2025	Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.; Lot: 25MAR032, Exp. 07/16/2025.	2,890 vials	Class III

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 25MAR032 on the product packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA published this recall 21 days after the firm started it.

Jul 9, 2025Firm started the recall
Jul 21, 2025FDA classified it Class III
Jul 30, 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/31987-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-0536-2025 (July 9, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0536-2025 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.