CLASS II Drug recall · Reported 25 Oct 2023 · FDA Enforcement Report
Lidocaine-phenylephrine 1%-1.5% Single Dose Vial recalled
Pine Pharmaceuticals is recalling Lidocaine-phenylephrine 1%-1.5% Single Dose Vial, distributed nationwide in the US. The recall was initiated on 2 Oct 2023 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-0059-2024
- FDA event ID
- 93154
- Recalling firm
- Pine Pharmaceuticals, Tonawanda, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Oct 2023
- FDA classified
- 19 Oct 2023
- Reported
- 25 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 2 Oct 2023 | Recall initiated by company | |
| 19 Oct 2023 | Classified by FDA | +17 days |
| 25 Oct 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Lidocaine-phenylephrine 1%-1.5% Single Dose Vial recalled?
Yes. Pine Pharmaceuticals recalled Lidocaine-phenylephrine 1%-1.5% Single Dose Vial on 2 Oct 2023. The recall is Class II and its status is Terminated. Recall number D-0059-2024.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot #: 67849, Exp. Date 10/25/2023; 67887, Exp. Date 10/28/2023; 68260, Exp. Date 11/14/2023; 68534, Exp. Date 11/27/2023; 68816, Exp. Date 12/12/2023; 69046, Exp. Date 12/20/2023; 69971, Exp. Date 1/13/2024
Where was it sold?
Nationwide within the United States
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 21 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 Pine Pharmaceuticals
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tropi-Phen (Tropicamide 1% phenylephrine HCl 5%) ophthalmic recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Foscarnet Sodium 4mg/ solution recalled by Pine Pharmaceuticals | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Endophth Kit (Vancomycin 1mg/ - Ceftazidime 25mg recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Bevacizumab 25 MG/ Solution for Injection syringes recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Tropi-Phen (tropicamide 1%, phenylephrine 5%) ophthalmic recalled | Pine Pharmaceuticals | Sterility | Nationwide |