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

Cefuroxime 4mg /0.4 mL

Reason Lack of Assurance of Sterility

Pine Pharmaceuticals, LLC D-0057-2024
Class II · Moderate risk Terminated

Tropi-Phen

Reason Lack of Assurance of Sterility

Pine Pharmaceuticals, LLC D-0055-2024
Class II · Moderate risk Terminated

Endophth Kit

Reason Lack of Assurance of Sterility

Pine Pharmaceuticals, LLC D-0052-2024
Class II · Moderate risk Terminated

EPINEPHrine added to dextrose 5%

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1131-2023
Class II · Moderate risk Terminated

EPINEPHrine added to 0.9% sodium chloride

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1130-2023
Class II · Moderate risk Terminated

EPINEPHrine

Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. D-1129-2023
Class II · Moderate risk Terminated

norepinephrine

Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Central Admixture Pharmacy Services, Inc. NDC 72196-8095-1 D-0988-2023
Class II · Moderate risk Terminated

EPINEPHrine 8mg/250ml added to dextrose 5%

Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Central Admixture Pharmacy Services, Inc. D-0959-2023
Class II · Moderate risk Terminated

EPINEPHrine added to dextrose 5%

Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Central Admixture Pharmacy Services, Inc. D-0958-2023
Class II · Moderate risk Terminated

EPINEPHrine

Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Central Admixture Pharmacy Services, Inc. D-0957-2023
Class II · Moderate risk Terminated

Norepinephrine 32 mg per 250 mL

Reason Lack of Assurance of Sterility

SterRx, LLC NDC 70324-702-01 D-0934-2023
Class II · Moderate risk Terminated

Norepinephrine 16 mg per 250 mL

Reason Lack of Assurance of Sterility

SterRx, LLC NDC 70324-602-01 D-0933-2023
Class II · Moderate risk Terminated

Norepinephrine 8 mg per 250 mL

Reason Lack of Assurance of Sterility

SterRx, LLC NDC 70324-577-01 D-0932-2023
Class II · Moderate risk Terminated

Norepinephrine 4 mg per 250 mL

Reason Lack of Assurance of Sterility

SterRx, LLC NDC 70324-552-01 D-0931-2023
Class II · Moderate risk Terminated

Atropine Sulfate Injection

Reason Presence of Particulate Matter: Particulate matter identified as fiber.

Accord Healthcare, Inc. NDC 16729-512-43 D-0917-2023
Class III · Low risk Terminated

Amlodipine Besylate Tablets

Reason Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.

Lupin Pharmaceuticals Inc. NDC 68180-721-03 D-0899-2023