Medications & Supplements/Prescription Drugs

Imprimis NJOF Epinephrine and Ophthalmic Solutions Recalled for Sub-potency

Agency Publication Date: July 21, 2025

Summary

Imprimis NJOF, LLC has recalled 9,770 vials of Epinephrine Lidocaine HCL injection and Tropicamide-Proparacaine-Phenylephrine-Ketorolac ophthalmic solution. The recall was initiated because stability testing showed the medications were sub-potent, meaning they contain less of the active drug ingredients than required. These products were distributed nationwide in the USA to medical facilities and providers.

Risk

Sub-potent drugs may not provide the expected therapeutic effect, which could result in inadequate anesthesia or ineffective pupil dilation and pain management during medical procedures. While no injuries have been reported, reduced drug strength in clinical settings can lead to procedural complications or patient discomfort.

What You Should Do

This recall affects Epinephrine Lidocaine HCL (0.25mg/mL and 7.5 mg/mL) and Tropicamide-Proparacaine-Phenylephrine-Ketorolac sterile ophthalmic solutions manufactured by Imprimis NJOF, LLC.
Identify the affected Epinephrine Lidocaine HCL vials by checking for NDC 71384-641-01 and lot number 24DEC017 with an expiration date of 07/12/2025.
Identify the affected Tropicamide-Proparacaine-Phenylephrine-Ketorolac vials by checking for NDC 71384-733-05 and lot number 25MAR032 with an expiration date of 07/16/2025.
Stop using the recalled product immediately to prevent ineffective treatment during medical procedures.
Contact the manufacturer or your distributor to arrange for the return of any remaining stock of these specific lots.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL (20x1 mL Vials per carton)

Variants: 0.25mg/mL, 7.5 mg/mL, Sterile Injection

Lot Numbers:

24DEC017 (Exp. 07/12/2025)

NDC:

71384-641-01

Quantity: 6,880 vials

Product: Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution (2x5ML vial per carton)

Variants: 1% 0.5% 2.5% 0.5%, 5mL vial, Eye solution

Lot Numbers:

25MAR032 (Exp. 07/16/2025)

NDC:

71384-733-05

Quantity: 2,890 vials

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97183

Status: Resolved

Manufacturer: Imprimis NJOF, LLC

Sold By: medical clinics; hospitals; healthcare providers

Manufactured In: United States

Units Affected: 2 products (6,880 vials; 2,890 vials)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

This recall affects Epinephrine Lidocaine HCL (0.25mg/mL and 7.5 mg/mL) and Tropicamide-Proparacaine-Phenylephrine-Ketorolac sterile ophthalmic solutions manufactured by Imprimis NJOF, LLC.

Identify the affected Epinephrine Lidocaine HCL vials by checking for NDC 71384-641-01 and lot number 24DEC017 with an expiration date of 07/12/2025.

Identify the affected Tropicamide-Proparacaine-Phenylephrine-Ketorolac vials by checking for NDC 71384-733-05 and lot number 25MAR032 with an expiration date of 07/16/2025.

Stop using the recalled product immediately to prevent ineffective treatment during medical procedures.

Contact the manufacturer or your distributor to arrange for the return of any remaining stock of these specific lots.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Affected Products

Product: Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL (20x1 mL Vials per carton)

Variants: 0.25mg/mL, 7.5 mg/mL, Sterile Injection

Lot Numbers:

24DEC017 (Exp. 07/12/2025)

NDC:

71384-641-01

Quantity: 6,880 vials

Product: Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution (2x5ML vial per carton)

Variants: 1% 0.5% 2.5% 0.5%, 5mL vial, Eye solution

Lot Numbers:

25MAR032 (Exp. 07/16/2025)

NDC:

71384-733-05

Quantity: 2,890 vials