US Drug Recall Register

Is Pine recalled?

Yes — there is an active recall. 82 ongoing FDA recalls mention Pine (685 total). Check the affected lots below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Pine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.

Class II · Moderate risk Terminated

QuadMix Injectable

Reason Lack of Assurance of Sterility

Northern VA Compounders PLLC D-0124-2023
Class II · Moderate risk Terminated

QuadMix Injectable

Reason Lack of Assurance of Sterility

Northern VA Compounders PLLC D-0120-2023
Class II · Moderate risk Terminated

QuadMix Super 002

Reason Lack of Assurance of Sterility

Northern VA Compounders PLLC D-0108-2023
Class II · Moderate risk Terminated

QuadMix Standard 001

Reason Lack of Assurance of Sterility

Northern VA Compounders PLLC D-0107-2023
Class II · Moderate risk Terminated

QuadMix Super 001

Reason Lack of Assurance of Sterility

Northern VA Compounders PLLC D-0105-2023
Class II · Moderate risk Terminated

QuadMix Standard 002

Reason Lack of Assurance of Sterility

Northern VA Compounders PLLC D-0104-2023
Class II · Moderate risk Terminated

QuadMix Plus

Reason Lack of Assurance of Sterility

Northern VA Compounders PLLC D-0103-2023
Class II · Moderate risk Terminated

Glycerin/Lidocaine Hcl/Epinephrine 31%

Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Pharmacy Innovations D-0213-2023
Class II · Moderate risk Terminated

Atropine sulfate 0.05%

Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Pharmacy Innovations D-0194-2023
Class II · Moderate risk Terminated

Epi-Caine

Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Pine Pharmaceuticals, LLC NDC 69194-0948-1 D-0130-2023
Class I · High risk Terminated

Epinephrine

Reason Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product

Spectrum Laboratory Products, Inc. D-0180-2023
Class I · High risk Terminated

Epinephrine

Reason Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product

Spectrum Laboratory Products, Inc. D-0179-2023
Class II · Moderate risk Terminated

Oxcarbazepine Tablets 600mg

Reason Presence of foreign substance

Sun Pharmaceutical Industries INC NDC 62756-185-88 D-0085-2023
Class II · Moderate risk Terminated

Sensorcaine-MPF

Reason Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Fresenius Kabi USA, LLC NDC 63323-468-01 D-0129-2023
Class II · Moderate risk Terminated

Sensorcaine

Reason Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Fresenius Kabi USA, LLC NDC 63323-463-01 D-0128-2023
Class II · Moderate risk Terminated

Sensorcaine

Reason Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Fresenius Kabi USA, LLC NDC 63323-461-01 D-0127-2023
Class II · Moderate risk Ongoing

PAP/PHEN/PROSTAG/ATROPINE INJ 150MG/7.5MG/75MCG/1MG bottle solution

Reason Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Pharmacy Plus, Inc. dba Vital Care Compounder D-0041-2023
Class II · Moderate risk Ongoing

LIDOCAINE EPINEPHRINE BUFFERED 2%/1:1000 Solution

Reason Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Pharmacy Plus, Inc. dba Vital Care Compounder D-0036-2023
Class II · Moderate risk Terminated

EPINEPHrine Injection

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-1251-2022
Class II · Moderate risk Terminated

EPINEPHrine Injection

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-1250-2022
Class II · Moderate risk Terminated

Atropine Sulfate Injection

Reason Lack of Assurance of Sterility

Nephron Sterile Compounding Center LLC D-1246-2022
Class II · Moderate risk Terminated

Racepinephrine Inhalation Solution

Reason CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office NDC 0487-5901-99 D-1325-2022
Class I · High risk Terminated

Nifedipine WSP 0.2% Ointment

Reason Subpotent and Superpotent Drug

Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy D-1286-2022