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 III · Low risk Terminated

Asenapine Sublingual Tablets

Reason Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent

SigmaPharm Laboratories LLC NDC 42794-016-10 D-0379-2021
Class II · Moderate risk Terminated

Epinephrine Injection USP

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 0093-5985-27 D-0578-2021
Class II · Moderate risk Terminated

Epinephrine Injection USP

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 0093-5986-27 D-0577-2021
Class II · Moderate risk Terminated

Benztropine Mesylate Tablets

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. D-0537-2021
Class II · Moderate risk Terminated

Epinephrine Injection

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. D-0528-2021
Class II · Moderate risk Terminated

Atropine Sulfate Ophthalmic Solution

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 17478-215-05 D-0410-2021
Class III · Low risk Terminated

Epinephrine/Lidocaine HCl

Reason Labeling: Incorrect or Missing Lot and/or Exp Date

Edge Pharma, LLC NDC 05446-0863-01 D-0307-2021
Class II · Moderate risk Terminated

Atropine Sulfate Injection

Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

SCA Pharmaceuticals D-0186-2021
Class II · Moderate risk Terminated

Sensorcaine-MPF

Reason Subpotent Drug: Low out-of-specification assay results for the epinephrine component.

Fresenius Kabi USA, LLC NDC 63323-462-01 D-0172-2021
Class III · Low risk Terminated

Felodipine Extended Release Tablets

Reason Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A

Heritage Pharmaceuticals Inc NDC 23155-050-01 D-0108-2021
Class III · Low risk Terminated

Nymalize

Reason Subpotent Drug

Arbor Pharmaceuticals Inc. NDC 24338-200-12 D-1625-2020
Class II · Moderate risk Terminated

Carbamazepine 200 mg Tablets

Reason FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.

RemedyRepack Inc. NDC 70518-2489-00 D-1387-2020
Class II · Moderate risk Terminated

Clozapine Tablets USP tablet

Reason Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.

Aurobindo Pharma USA Inc. NDC 65862-846-05 D-1370-2020
Class III · Low risk Terminated

Olanzapine Tablets

Reason Failed Impurities/ Degradation Specifications

Aurobindo Pharma USA Inc. NDC 66993-682-30 D-1315-2020
Class III · Low risk Terminated

Olanzapine Tablets

Reason Failed Impurities/ Degradation Specifications

Aurobindo Pharma USA Inc. NDC 66993-680-30 D-1314-2020
Class II · Moderate risk Terminated

Carbamazepine Tablets

Reason Failed Dissolution Specifications

Torrent Pharma Inc. NDC 13668-268-05 D-1317-2020
Class III · Low risk Terminated

R.E.C.K.

Reason Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac

QuVa Pharma, Inc. D-1335-2020
Class II · Moderate risk Terminated

Mirtazapine Tablets

Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Aurobindo Pharma USA Inc. NDC 13107-031-34 D-1235-2020
Class II · Moderate risk Terminated

nICARdipine HCl

Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.

PharMEDium Services, LLC NDC 71019-206-01 D-1082-2020
Class II · Moderate risk Terminated

Epinephrine Injection USP

Reason CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.

Teva Pharmaceuticals USA NDC 0093-5986-27 D-1260-2020
Class III · Low risk Terminated

Quetiapine Fumarate Extended-Release Tablets

Reason Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

The Harvard Drug Group D-1002-2020