CLASS II Drug recall · Reported 23 Nov 2022 · FDA Enforcement Report
Timolol-Latanoprost (0.5/0.005%) ophthalmic drops recalled
ImprimisRx NJ is recalling Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, Imprimis Rx, Ledgewood, NJ, distributed nationwide in the US. The recall was initiated on 9 Nov 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0060-2023
- FDA event ID
- 91140
- Recalling firm
- ImprimisRx NJ, Ledgewood, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Nov 2022
- FDA classified
- 14 Nov 2022
- Reported
- 23 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 9 Nov 2022 | Recall initiated by company | |
| 14 Nov 2022 | Classified by FDA | +5 days |
| 23 Nov 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
Which lots are affected?
Lot # 06272022@3, Exp. date 11/24/2022 Lot # 08302022@1, Exp. date 01/27/2023
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from ImprimisRx NJ
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic recalled | ImprimisRx NJ | Potency & Assay | Nationwide |
| Drug | CLASS II | Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops recalled | ImprimisRx NJ | Potency & Assay | Nationwide |
| Drug | CLASS II | Timolol- Dorzolamide- Latanoprost recalled by ImprimisRx NJ | ImprimisRx NJ | Potency & Assay | Nationwide |