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

387 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2017 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Hcg *10ml* Mdv 500u/Ml Inj

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0720-2017
Class II · Moderate risk

Folinic Acid Mdv Inj

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0719-2017
Class II · Moderate risk

Folinic Acid Mdv

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0718-2017
Class II · Moderate risk

Folic Acid 1ml Sdv 10mg/Ml Inj

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0717-2017
Class II · Moderate risk

Dmso 6.25% Ophth.

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0715-2017
Class II · Moderate risk

Dmps Acid *5ml* Sdv 50mg/Ml Inj

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0714-2017
Class II · Moderate risk

Co-Q-10 Oil 20ml Mdv

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0713-2017
Class II · Moderate risk

Atropine Sulfate 0.5% Ophth

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0712-2017
Class II · Moderate risk

Atropine Sulfate 0.01% Ophth

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0711-2017
Class II · Moderate risk

5-Mthf Sdv 5mg/Ml Inj

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0710-2017
Class II · Moderate risk

5-Mthf 10ml Sdv

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0709-2017
Class II · Moderate risk

5-Mthf 10ml Mdv

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0708-2017
Class II · Moderate risk

5-Mthf *10ml* Mdv 5mg/Ml Inj

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Terminated Sterility / contamination Key Pharmacy and Compounding Center D-0707-2017
Class II · Moderate risk

Phenylephrine 2.5%

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Terminated Sterility / contamination Isomeric Pharmacy Solution, LLC D-0687-2017
Class II · Moderate risk

Testosterone Cypionate 200 mg/mL

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Terminated Sterility / contamination Isomeric Pharmacy Solution, LLC D-0686-2017
Class II · Moderate risk

Triamcinolone Diacetate 40 mg/mL

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Terminated Sterility / contamination Isomeric Pharmacy Solution, LLC D-0684-2017
Class II · Moderate risk

Triamcinolone Acetonide 40 mg/mL

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Terminated Sterility / contamination Isomeric Pharmacy Solution, LLC D-0683-2017
Class II · Moderate risk

Metronidazole Injection

Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.

Terminated Sterility / contamination Claris Lifesciences Inc NDC 36000-001-24 D-0616-2017
Class II · Moderate risk

Levofloxacin Injection in 5% Dextrose

Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.

Terminated Sterility / contamination Claris Lifesciences Inc NDC 36000-048-24 D-0615-2017
Class II · Moderate risk

Fluconazole Injection

Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.

Terminated Sterility / contamination Claris Lifesciences Inc NDC 36000-003-06 D-0614-2017

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