Compounded quadruple ophthalmic solution returned subpotent assay results in stability testing
A compounded Tropicamide-Proparacaine-Phenylephrine-Ketorolac sterile ophthalmic solution is being recalled because of subpotent assay results during stability testing. 2,890 vials are affected.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall for an out-of-specification potency result, which the rubric places in the low band, with no health consequence stated.
Plain-English summary
Tropicamide-Proparacaine-Phenylephrine-Ketorolac Sterile Ophthalmic Solution, 1% / 0.5% / 2.5% / 0.5%, 5 mL, two 5 mL vials per carton, prescription only, from Imprimis NJOF, LLC of Ledgewood, New Jersey, NDC 71384-733-05, is being recalled. The action covers 2,890 vials.
The stated reason is a sub-potent drug: subpotent assay results during stability testing. The FDA classified the action as Class III, its least serious classification.
The affected lot is 25MAR032, expiring 07/16/2025. Distribution was nationwide in the USA. The vials are supplied to eye care facilities rather than sold to consumers.
Facilities should identify affected stock using the NDC and lot number above and follow the instructions issued by the compounder.
The recalled product
- Product
- 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.
- Manufacturer
- Imprimis NJOF, LLC
- Affected units
- 2,890
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 25MAR032
- Exp. 07/16/2025.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Imprimis NJOF, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Imprimis NJOF, LLC
See all →- HighTri-Moxi intraocular injection recalled over glass-like particulate matter
FDA (Drugs) · 2026-01-14
- HighIntraocular injection syringes recalled over glass-like particulate matter
FDA (Drugs) · 2026-01-14
- HighDexamethasone and moxifloxacin injection recalled over glass-like particulate matter
FDA (Drugs) · 2026-01-14
- ModerateCyclosporine eye drops recalled as subpotent across many compounded lots
FDA (Drugs) · 2025-11-26
- HighCompounded epinephrine lidocaine vials returned subpotent assay results in stability testing
FDA (Drugs) · 2025-07-30
Same hazard · subpotent
See all →- ModerateCAREone Earwax Removal Drops Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2026-07-22
- HighCompounded vasopressin syringes recalled as subpotent by IntegraDose Compounding Services
FDA (Drugs) · 2026-06-24
- ModerateSkin Rehab calming hydrocortisone balm recalled as a subpotent drug
FDA (Drugs) · 2026-04-22
- Moderateglo Skin Beauty Remedy Gel recalled as a subpotent hydrocortisone product
FDA (Drugs) · 2026-04-22
- ModerateRhonda Allison calming skin gel recalled as a subpotent hydrocortisone product
FDA (Drugs) · 2026-04-22
Similar recalls
- ModerateSterile ophthalmic solution recalled for subpotent drug strength
FDA (Drugs) · 2025-04-09
- ModerateOphthalmic Solution Recalled Due to Subpotent Ketorolac Levels
FDA (Drugs) · 2023-10-25
- HighFDA Issues Nationwide Recall of Subpotent Ophthalmic Eye Drops
FDA (Drugs) · 2024-05-08
- HighFDA Recalls Eye Suspension Medication for Lack of Sterility Assurance
FDA (Drugs) · 2024-06-19
- ModerateCompounded Ophthalmic Medication Bottles Mislabeled as Single-Use Syringes
FDA (Drugs) · 2023-12-06
- SevereEye Drops Recalled for Lack of Sterility Assurance by Edge Pharma
FDA (Drugs) · 2022-02-02