Use caution Drug recall · FDA · Published September 20, 2023

Imprimis Recalls MYDRIATIC-4 Eye Drops Due to Subpotent Ketorolac

Imprimis NJOF recalls MYDRIATIC-4 ophthalmic solution drops because Ketorolac levels are below label claim. Check lot numbers and expiration dates.

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

🇺🇸 FDA recall #D-0043-2024Drug Imprimis NJOF ›

Use caution until it’s fixed

Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Imprimis NJOF, LLC is recalling MYDRIATIC-4 sterile ophthalmic solution drops because the Ketorolac ingredient was found to be subpotent, with assay levels falling below the required specification. This means the medication may not work as intended for patients relying on it during eye procedures. The product was distributed to physician offices across the country. Read more at govinfonow.com/recall/33130-imprimis-recalls-mydriatic-4-eye-drops-due-to-subpotent-ketorolac.

Source Summary by GovInfoNow · govinfonow.com/recall/33130-imprimis-recalls-mydriatic-4-eye-drops-due-to-subpotent-ketorolac · Updated October 9, 2026 · FDA enforcement record: FDA #D-0043-2024

Cite this page

“Imprimis Recalls MYDRIATIC-4 Eye Drops Due to Subpotent Ketorolac.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/33130-imprimis-recalls-mydriatic-4-eye-drops-due-to-subpotent-ketorolac. Based on FDA recall #D-0043-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0043-2024%22&limit=1).

The FDA announced on September 20, 2023, that Imprimis NJOF, LLC voluntarily recalled MYDRIATIC-4 Eye Drops due to subpotent Ketorolac levels. The Class III recall affects products distributed to physician offices nationwide.

How to tell if you have it

Brand: Imprimis NJOF
Product: MYDRIATIC-4 Eye Drops (Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops)
NDC: 71384-632-05
Lot codes: 22DEC065, 23JAN024, 23FEB024, 23MAR013, 23MAR033, 23MAY044
Expiration dates: 09/29/2023, 10/13/2023, 11/09/2023, 12/01/2023, 12/16/2023, 03/23/2024
Quantity: 6,228 bags and 15,360 boxes

The hazard

The FDA said the product poses a hazard because out-of-specification results were observed for Ketorolac assay levels, which fell below the required 90.0-110.0% of label claim.

Context

GovInfoNow's records show Imprimis NJOF, LLC has 13 other recalls on record since December 17, 2020. Other recent recalls include an intraocular injection with glass particles (December 18, 2025), Klarity-C Drops for subpotent drug risk (October 20, 2025), and Imprimis Epinephrine Vials for sub-potent drug risk (July 9, 2025). Other recent recalls of similar products include ImprimisRx Povidone Iodine Ophthalmic Solution (August 24, 2026) and K.C. Pharmaceuticals Dry Eye Relief Eye Drops (March 3, 2026).

How to tell if you have this one

Look for MYDRIATIC-4 bottles containing Tropicamide, Proparacaine, Phenylephrine, and Ketorolac (1% - 0.5% - 2.5% - 0.5%) in 5mL containers. Check the NDC 71384-632-05 and specific lot numbers: 22DEC065, 23JAN024, 23FEB024, 23MAR013, 23MAR033, or 23MAY044.

Brand
Imprimis NJOF
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Lot Numbers
Verify if your eye drops match the recalled lot numbers and expiration dates listed in the record.
Contact Your Doctor
If you have one of the affected lots, contact the physician office where you received the drops for further instructions.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Product was distributed to physician's offices nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 22 months after the firm started it.

Sep 20, 2023Firm started the recall
Oct 13, 2023FDA classified it Class III
Oct 25, 2023Published in FDA’s Enforcement Report
Jul 17, 2025FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Where was this product sold?

The product was distributed to physician's offices nationwide, not directly to consumers in stores.

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Link to this recall

<a href="https://govinfonow.com/recall/33130-imprimis-recalls-mydriatic-4-eye-drops-due-to-subpotent-ketorolac">Imprimis Recalls MYDRIATIC-4 Eye Drops Due to Subpotent Ketorolac (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-0043-2024 (September 20, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0043-2024 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.