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

18,003 recalls, newest first

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

Hands Down Medicated Lotion Soap

Labeling: Presence of Undeclared Additive: Medicated lotion soap produced and distributed by the recalling firm contains the unapproved ingredient, Red Dye #15. This dye is not approved for use in food, drugs or cosmetics.

Terminated Labeling / mix-up Kutol Products Co Inc D-1387-2012
Class I · High risk

a) Firminite 805 mg is packaged in 2 count

Marketed Without an Approved NDA/ANDA: These products found to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs.

Terminated Chemical / undeclared InSo-Independent Contractor for West Coast Nutritionals,LTD D-326-2013
Class II · Moderate risk

Zemplar (paricalcitol)

CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in a specific lot of Zemplar Injection.

Terminated cGMP deviation Abbott Laboratories NDC 0074-1658-05 D-1388-2012
Class I · High risk

HYDROmorphone HCl Injection

Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume.

Terminated Wrong potency / content Hospira Inc. NDC 0409-1283-31 D-1444-2012
Class III · Low risk

Morton

Impurities/Degradation Products: The product was found to contain a slightly out of specification level of bromides, exceeding the bromides limit for USP Sodium Chloride.

Terminated Impurity / degradation Morton Salt Co. D-1656-2012
Class II · Moderate risk

Estradiol Hemihydrate M20 EP/USP Powder

Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.

Terminated Cross-contamination Bayer HealthCare Pharmaceuticals Inc. D-1433-2012
Class III · Low risk

Endocet (oxycodone and acetaminophen)

Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets.

Terminated Particulate / foreign matter Endo Pharmaceuticals, Inc. NDC 60951-797-70 D-1381-2012

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