Epi-Caine (Pine Pharmaceuticals) – Raw Material Discoloration (2022)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial, Compounded by Pine Pharmaceuticals, 355 Riverwalk Pkwy, Tonawanda, NY 14150. NDC 69194-0948-1
Brand
Pine Pharmaceuticals, LLC
Lot Codes / Batch Numbers
Lot # 62881, Exp 12/25/2022, 62923, Exp 12/26/2022, 63066, Exp 01/03/2023, 63067, Exp 01/01/2023, 63103, Exp 01/02/2023, 63120, Exp 01/03/2023, 63219, 63226, Exp 01/08/2023, 63263, Exp 01/09/2023, 63380, 63381, Exp 01/15/2023, 63433, Exp 01/16/2023, 63455, Exp 01/17/2023, 63537, Exp 01/22/2023, 63580, Exp 01/23/2023, 63721, Exp 01/29/2023, 63792, Exp 01/31/2023, 63888, Exp 02/05/2023, 63930, Exp 02/06/2023, 63959, Exp 02/07/2023, 64079, Exp 02/13/2023, 64109, Exp 02/14/2023, 64239, Exp 02/21/2023.
Products Sold
Lot # 62881, Exp 12/25/2022; 62923, Exp 12/26/2022; 63066, Exp 01/03/2023; 63067, Exp 01/01/2023; 63103, Exp 01/02/2023; 63120, Exp 01/03/2023; 63219, 63226, Exp 01/08/2023; 63263, Exp 01/09/2023; 63380, 63381, Exp 01/15/2023; 63433, Exp 01/16/2023; 63455, Exp 01/17/2023; 63537, Exp 01/22/2023; 63580, Exp 01/23/2023; 63721, Exp 01/29/2023; 63792, Exp 01/31/2023; 63888, Exp 02/05/2023; 63930, Exp 02/06/2023; 63959, Exp 02/07/2023; 64079, Exp 02/13/2023; 64109, Exp 02/14/2023; 64239, Exp 02/21/2023.
Pine Pharmaceuticals, LLC is recalling Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single D due to CGMP Deviations: Raw material recalled by repackager, due to discoloration.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026