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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 61–65 of 65 recalls

Class IIICompleted

Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.

Imprimis NJOF, LLC

Sub-Potent Drug: Subpotent assay results during stability testing.

July 9, 2025 · DrugView details →

Class IIIOngoing

Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496

Boothwyn Pharmacy LLC

Subpotent Drug

July 9, 2025 · DrugView details →

Class IIIOngoing

Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90

AvKARE

Failed Impurity/Degradation Specifications

June 26, 2025 · DrugView details →

Class IIIOngoing

Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90

AvKARE

Failed Impurity/Degradation Specifications

June 26, 2025 · DrugView details →

Class IIIOngoing

Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01

Qualgen, LLC

Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.

June 16, 2025 · DrugView details →

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