Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

1,273 recalls, newest first

Class II · Moderate risk

Avastin

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Oregon Compounding Centers, Inc. dba Creative Compounds D-0177-2015
Class II · Moderate risk

Ascorbic Acid

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Oregon Compounding Centers, Inc. dba Creative Compounds D-0176-2015
Class II · Moderate risk

Ascorbic Acid

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Oregon Compounding Centers, Inc. dba Creative Compounds D-0175-2015
Class II · Moderate risk

Alprostadil/Lidocaine HCL

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Oregon Compounding Centers, Inc. dba Creative Compounds D-0174-2015
Class II · Moderate risk

Alprostadil

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Oregon Compounding Centers, Inc. dba Creative Compounds D-0173-2015
Class II · Moderate risk

CVS pharmacy

Microbial Contamination of Non-Sterile Products: CVS Pharmacy Pain Relieving Antiseptic Spray tested positive for microbial growth.

Terminated Microbial contamination Wisconsin Pharmacal Company NDC 68093-6150-1 D-0047-2015
Class II · Moderate risk

Ketorolac Tromethamine INJECTION

Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.

Terminated Stability / shelf life Sagent Pharmaceuticals Inc NDC 25021-701-01 D-0027-2015
Class III · Low risk

candesartan cilexetil

Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.

Terminated Impurity / degradation Sandoz, Inc NDC 0781-5938-92 D-0288-2015
Class III · Low risk

Hydrocortisone Butyrate Cream 0.1%

Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point

Terminated Wrong potency / content Valeant Pharmaceuticals International NDC 43478-270-15 D-0025-2015
Class III · Low risk

Amlodipine Besylate Tablets

Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.

Terminated Failed specification Zydus Pharmaceuticals USA Inc NDC 68382-123-16 D-0257-2015
Class II · Moderate risk

DOPamine Hydrochloride and 5% Dextrose INJ

Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.

Terminated Sterility / contamination Baxter Healthcare Corp. NDC 0338-1005-02 D-0004-2015
Class II · Moderate risk

Bystolic (nebivolol)

Failed Dissolution Specification; at the 6-month stability time point

Terminated Dissolution failure Forest Pharmaceuticals Inc NDC 0456-1420-07 D-0036-2015
Class III · Low risk

BENZONATATE Capsules

Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.

Terminated Particulate / foreign matter Zydus Pharmaceuticals USA Inc D-0289-2015
Class II · Moderate risk

Cephalexin Monohydrate Capsules

CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.

Terminated cGMP deviation Physicians Total Care, Inc. D-0237-2015
Class II · Moderate risk

Xarelto (rivaroxaban)

Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.

Terminated Microbial contamination Janssen Ortho L.L.C. NDC 50458-578-99 D-0006-2015

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