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

5,405 recalls, newest first

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

Lidocaine/Epinephrine/Bupivacaine

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1561-2012
Class II · Moderate risk

Lidocaine Hcl/Epinephrine in Bss - P.F.

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1560-2012
Class II · Moderate risk

Lidocaine Hcl/Bupivacaine HCL Pf 1%/0.375% Ophthalmic 30 Ml …

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1559-2012
Class II · Moderate risk

Lidocaine HCL

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1558-2012
Class II · Moderate risk

Levothyroxine Sodium 325mcg/Ml

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1557-2012
Class II · Moderate risk

Levofloxacin

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1556-2012
Class II · Moderate risk

Leucovorin

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1555-2012
Class II · Moderate risk

L-Arginine 500mg/Ml Injectable 2500 Ml 500 Ml

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1554-2012
Class II · Moderate risk

Labetalol Hydrochloride 5mg/Ml Injectable 100 Ml 80 Ml

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1553-2012
Class II · Moderate risk

Ketorolac Tromethamine 30mg/Ml Injectable 10 Ml 24 Ml 500 Ml

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1552-2012
Class II · Moderate risk

Kenalog-40**

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1551-2012
Class II · Moderate risk

Isosulfan Blue 1% Injectable 10 Ml 15 Ml

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1550-2012
Class II · Moderate risk

Iopamidol 41% Injectable 198 Ml 99 Ml 50 Ml 600 Ml 72 Ml

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1549-2012
Class II · Moderate risk

Iohexol 200mg Iodine/Ml Injectable 120 Ml 300 Ml 50 Ml 600 Ml 72 Ml

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1548-2012
Class II · Moderate risk

Insulin

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1547-2012
Class II · Moderate risk

1.5% Glycine Irrigation

Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.

Terminated Sterility / contamination Hospira Inc. NDC 0409-7974-08 D-618-2013
Class II · Moderate risk

20% Dextrose Injection

Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.

Terminated Sterility / contamination Hospira Inc. NDC 0409-7935-19 D-616-2013
Class II · Moderate risk

5% Dextrose Injection USP

Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.

Terminated Sterility / contamination Hospira Inc. NDC 0409-7922-02 D-614-2013
Class II · Moderate risk

70% Dextrose Injection USP

Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.

Terminated Sterility / contamination Hospira Inc. NDC 0409-7120-07 D-612-2013
Class II · Moderate risk

ChloraPrep One-Step

Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.

Terminated Sterility / contamination Carefusion 213, Llc NDC 54365-400-01 D-004-2013

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