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

1,803 recalls · Class II, newest first

Class II · Moderate risk

PGE-1 Inj 30mcg/ml MDV

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-459-2013
Class II · Moderate risk

PGE-1 Inj 20mcg/ml MDV: 5ml

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-458-2013
Class II · Moderate risk

PGE-1 Inj 10mcg/ml MDV

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-457-2013
Class II · Moderate risk

Papaverine Inj 30mg/ml Syr

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-456-2013
Class II · Moderate risk

Bimix Inj 30:1 MDV: 5ml

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-455-2013
Class II · Moderate risk

Bimix Inj 30:0.5 MDV

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-454-2013
Class II · Moderate risk

Bimix Inj 30 :1 Syr

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Terminated Sterility / contamination Nora Apothecary and Alternative Therapies, Inc. D-453-2013
Class II · Moderate risk

Walmart Amlodipine Besylate Tablets

Labeling: Label Error on Declared Strength-The recalled product has a misprint on the Amoldipine 10 mg label, 5 mg is listed in the USP description. Tablet strength is 10 mg.

Terminated Labeling / mix-up Legacy Pharmaceutical Packaging LLC NDC 68645-445-70 D-319-2013
Class II · Moderate risk

Glimepiride Tablets USP

Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level.

Terminated Failed specification Qualitest Pharmaceuticals NDC 0603-3745-21 D-298-2013
Class II · Moderate risk

Amoxicillin Capsules USP 500 mg

Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.

Terminated Particulate / foreign matter Sandoz Incorporated NDC 0781-2613-05 D-268-2013
Class II · Moderate risk

Cyclosporin in Corn Oil Injectable Balanced Solutions

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-295-2013
Class II · Moderate risk

BiMix Customs Injectable Balanced Solutions

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-294-2013
Class II · Moderate risk

Sodium Tetradecyl Sulfate for Injectable Balanced Solutions

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-293-2013
Class II · Moderate risk

Triamcinolone Acetonide Injectable Balanced Solutions

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-291-2013
Class II · Moderate risk

Triamcinolone Diacetate Injectable Balanced Solutions

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-290-2013
Class II · Moderate risk

QuadMix Injectable Balanced Solutions

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-287-2013
Class II · Moderate risk

Quadmix Custom Injectable Balanced Solutions

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-285-2013
Class II · Moderate risk

BiMix Plus Injectable Balanced Solutions

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-284-2013
Class II · Moderate risk

BiMix Standard Injectable Balanced Solutions

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-283-2013
Class II · Moderate risk

Trimix Customs Injectable Balanced Solutions

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-282-2013
Class II · Moderate risk

Mono-mix (Prostaglandin)

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-281-2013

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