Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA drug recalls in 2014

Every FDA drug recall initiated in 2014, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.

1,309 recalls, newest first.

Class II · Moderate risk

ROHTO Redness Relief

Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.

Terminated Sterility / contamination The Mentholatum Co. D-1041-2014
Class II · Moderate risk

ROHTO Cooling Eye Drops

Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.

Terminated Sterility / contamination The Mentholatum Co. D-1040-2014
Class II · Moderate risk

ROHTO Dry Eye

Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.

Terminated Sterility / contamination The Mentholatum Co. D-1039-2014
Class II · Moderate risk

ROHTO Redness Relief

Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.

Terminated Sterility / contamination The Mentholatum Co. D-1038-2014
Class II · Moderate risk

ROHTO Redness Relief

Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.

Terminated Sterility / contamination The Mentholatum Co. D-1037-2014
Class II · Moderate risk

Guaifenesin USP

Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a screen used to sift the Guaifenesin.

Terminated Particulate / foreign matter Traxx International Corp D-1165-2014
Class II · Moderate risk

Levothyroxine Sodium Tablets

Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.

Terminated Wrong potency / content Mylan Pharmaceuticals Inc. NDC 0378-1819-01 D-1084-2014
Class I · High risk

PRO ArthMax Dietary Supplement tablets

Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin

Terminated Unapproved drug Human Science Foundation D-1327-2014
Class III · Low risk

Liptruzet (ezetimibe and atorvastin)

Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.

Terminated Failed specification Merck & Co Inc NDC 66582-323-30 D-1312-2014
Class III · Low risk

Liptruzet (ezetimibe and atorvastin)

This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.

Terminated Failed specification Merck & Co Inc NDC 66582-322-30 D-1311-2014
Class III · Low risk

Liptruzet (ezetimibe and atorvastin)

This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.

Terminated Failed specification Merck & Co Inc NDC 66582-321-30 D-1310-2014
Class III · Low risk

Liptruzet (ezetimibe and atorvastin)

This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.

Terminated Failed specification Merck & Co Inc NDC 66582-320-30 D-1309-2014
Class I · High risk

DOBUTamine Injection

Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution.

Terminated Particulate / foreign matter Hospira Inc. NDC 0409-2344-02 D-1540-2014
Class II · Moderate risk

Dermamedics Calm and Correct Serum

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

Terminated Unapproved drug Dermamedics, L.L.C. D-1491-2014
Class II · Moderate risk

Dermamedics Post Procedure Cream

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

Terminated Unapproved drug Dermamedics, L.L.C. D-1487-2014
Class I · High risk

Xzen Platinum

Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

Terminated Chemical / undeclared Schindele Enterprises dba Midwest Wholesale D-1340-2014
Class I · High risk

ExtenZe 600 mg

Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

Terminated Chemical / undeclared Schindele Enterprises dba Midwest Wholesale D-1339-2014

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