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

129 recalls · Class III, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2014 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class III · Low risk

3M ESPE Clinpro 5000

Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date stamp on the primary box..

Terminated Labeling / mix-up 3M Company/3m Espe Dental Products NDC 48878-3130-04 D-0376-2015
Class III · Low risk

sulfur8

Failed pH specification: Product pH test value of 5.72 failed to meet its product specification of 6.0 to 7.5.

Terminated Failed specification J. Strickland and Co D-0318-2015
Class III · Low risk

BELVIQ¿ (Lorcaserin HCl)

Labeling:Missing Label: Bottles may not have a product label, or have a label with missing or illegible lot number and/or expiry date.

Terminated Labeling / mix-up Eisai Inc D-0302-2015
Class III · Low risk

Fluoxetine Capsules USP

Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.

Terminated Labeling / mix-up Sandoz Incorporated NDC 0781-2822-01 D-0291-2015
Class III · Low risk

Simvastatin Tablets

Failed Impurities/Degradation Specifications: Product failed a known impurity specification.

Terminated Impurity / degradation Micro Labs Usa, Inc S NDC 42571-080-90 D-0409-2015
Class III · Low risk

Simvastatin Tablets

Failed Impurities/Degradation Specifications: Product failed a known impurity specification.

Terminated Impurity / degradation Micro Labs Usa, Inc S NDC 42571-0040-90 D-0408-2015
Class III · Low risk

Simvastatin Tablets

Failed Impurities/Degradation Specifications: Product failed a known impurity specification.

Terminated Impurity / degradation Micro Labs Usa, Inc S NDC 42571-0020-10 D-0407-2015
Class III · Low risk

Eye Drops Advanced Relief

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

Terminated cGMP deviation K C Pharmaceuticals Inc D-0323-2015
Class III · Low risk

Eye Drops Industrial Strength

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

Terminated cGMP deviation K C Pharmaceuticals Inc D-0322-2015
Class III · Low risk

Eye Drops A.C.

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

Terminated cGMP deviation K C Pharmaceuticals Inc D-0321-2015
Class III · Low risk

Eye Drops (Tetrahydrozoline HCl 0.05%)

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

Terminated cGMP deviation K C Pharmaceuticals Inc D-0320-2015
Class III · Low risk

Dacarbazine

Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled conditions.

Terminated Failed specification Hospira Inc. NDC 61703-327-22 D-0313-2015
Class III · Low risk

Mucinex DM

Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch

Terminated Packaging defect Reckitt Benckiser LLC NDC 63824-056-72 D-0964-2015
Class III · Low risk

Scrub Care Chlorhexidine Gluconate Solution

Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to higher concentrations of available chlorhexidine gluconate.

Terminated Unapproved drug CareFusion 213, LLC NDC 57613-007-25 D-0298-2015
Class III · Low risk

Carbamazepine Tablets USP

Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval.

Terminated Unapproved drug Taro Pharmaceuticals U.S.A., Inc. NDC 51672-4005-3 D-0049-2015
Class III · Low risk

Z-Cote Hp 1 Transparent Zinc Oxide

cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1.

Terminated cGMP deviation Nanophase Technologies Corporation D-0238-2015
Class III · Low risk

Candesartan Cilexetil Tablets

Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

Terminated Impurity / degradation Apotex Inc. NDC 60505-3621-3 D-0244-2015
Class III · Low risk

Candesartan Cilexetil Tablets

Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

Terminated Impurity / degradation Apotex Inc. NDC 60505-3620-3 D-0243-2015
Class III · Low risk

Candesartan Cilexetil Tablets

Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

Terminated Impurity / degradation Apotex Inc. NDC 60505-3619-3 D-0242-2015
Class III · Low risk

Candesartan Cilexetil Tablets

Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

Terminated Impurity / degradation Apotex Inc. NDC 60505-3618-3 D-0241-2015
Class III · Low risk

TORISEL Kit

Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The TORISEL vials are not affected by this issue.

Terminated Failed specification Pfizer Inc. NDC 0008-1179-01 D-0235-2015

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