Independent register of U.S. FDA drug recalls · updated Oct 11, 2026
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FDA Drug Recalls

11,818 recalls · Class II, newest first

Class II · Moderate risk

Tri-mix Antidote 10 each Syringes

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled 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 Perry Drug Inc. NDC 88888-0205-17 D-0266-2015
Class II · Moderate risk

HCG Low Dose 30 IU/0.1 mL

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled 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 Perry Drug Inc. NDC 88888-0231-54 D-0265-2015
Class II · Moderate risk

Testosterone Cyp 200 mg/mL Sesame Inj.

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled 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 Perry Drug Inc. NDC 88888-7906-71 D-0264-2015
Class II · Moderate risk

Phenylephrine HCl

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled 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 Perry Drug Inc. NDC 88888-5230-12 D-0263-2015
Class II · Moderate risk

Leuprolide 50 mcg/0.1 mL Micro Lupron Kit

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled 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 Perry Drug Inc. NDC 88888-1124-57 D-0262-2015
Class II · Moderate risk

Tri-Mix

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled 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 Perry Drug Inc. NDC 88888-5123-09 D-0261-2015
Class II · Moderate risk

Methyl B12 25 mg/mL Inj.

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled 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 Perry Drug Inc. NDC 88888-2014-37 D-0260-2015
Class II · Moderate risk

Testosterone CYP-250/PROP-20 mg

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled 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 Perry Drug Inc. NDC 88888-0326-44 D-0259-2015
Class II · Moderate risk

Mercaptopurine Tablets

Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

Terminated Dissolution failure Prometheus Laboratories Inc. NDC 49884-922-02 D-0249-2015
Class II · Moderate risk

Gabapentin Capsules

Failed Tablet/Capsule Specifications: Complaints of empty capsules received.

Terminated Failed specification Aurobindo Pharma USA Inc NDC 16714-662-01 D-0330-2015
Class II · Moderate risk

Obagi Nu-Derm Clear

Labeling: Label Mix-Up; Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadvertently introduced into the Obagi Exfoderm Forte packaging line. Therefore customers which ordered Clear RX actually had contents of Exfoderm forte.

Terminated Labeling / mix-up Obagi Medical Products NDC 62032-101-36 D-0234-2015
Class II · Moderate risk

Cyproheptadine HCl Syrup

Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.

Terminated Impurity / degradation Pharmaceutical Associates Inc NDC 0121-4788-10 D-0240-2015
Class II · Moderate risk

Tri-mix #4

Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.

Terminated Sterility / contamination Vann Healthcare Services Inc D-0312-2015
Class II · Moderate risk

Lidocaine 4% Syr

Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.

Terminated Sterility / contamination Vann Healthcare Services Inc D-0311-2015
Class II · Moderate risk

Epinephrine 1:1000

Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.

Terminated Sterility / contamination Vann Healthcare Services Inc D-0310-2015
Class II · Moderate risk

Hydroxyprogesterone Caproate

Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.

Terminated Sterility / contamination Vann Healthcare Services Inc D-0309-2015
Class II · Moderate risk

Sterile Water for Injection

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Terminated Sterility / contamination Hospira Inc. NDC 0409-7990-09 D-0287-2015
Class II · Moderate risk

0.45% Sodium Chloride Injection

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Terminated Sterility / contamination Hospira Inc. NDC 0409-7985-09 D-0286-2015
Class II · Moderate risk

0.9% Sodium Chloride Injection

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Terminated Sterility / contamination Hospira Inc. NDC 0409-7983-09 D-0285-2015
Class II · Moderate risk

Lactated Ringer's Injection

Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.

Terminated Sterility / contamination Hospira Inc. NDC 0409-7953-09 D-0283-2015

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