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

1,525 recalls · Class III, 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 III · Low risk

Cataflam (diclofenac potassium)

Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.

Terminated Failed specification Novartis Pharmaceuticals Corp. NDC 0078-0436-05 D-1516-2014
Class III · Low risk

Clonidine HCl Injection

Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride".

Terminated Labeling / mix-up X-Gen Pharmaceuticals Inc. NDC 39822-2000-1 D-1444-2014
Class III · Low risk

VIRACEPT (nelfinavir mesylate)

Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016.

Terminated Labeling / mix-up Pfizer Inc. NDC 63010-027-70 D-1443-2014
Class III · Low risk

Triamcinolone Acetonide Lotion USP

Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.

Terminated Failed specification Fougera Pharmaceuticals Inc. NDC 0168-0336-60 D-1441-2014
Class III · Low risk

Triamcinolone Acetonide Lotion USP

Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.

Terminated Failed specification Fougera Pharmaceuticals Inc. NDC 0168-0337-60 D-1440-2014
Class III · Low risk

Diltiazem HCl Extended-release Capsules

Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.

Terminated Impurity / degradation Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-947-08 D-1435-2014
Class III · Low risk

E-Z-HD (barium sulfate)

Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.

Terminated Wrong potency / content Bracco Diagnostic Inc NDC 32909-764-01 D-1536-2014
Class III · Low risk

Lortuss Ex

Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".

Terminated Unapproved drug Poly Pharmaceuticals, Inc D-1432-2014
Class III · Low risk

Poly-Tussin Ac Liquid

Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".

Terminated Unapproved drug Poly Pharmaceuticals, Inc D-1431-2014
Class III · Low risk

Diltiazem HCl Extended Release Capsules

Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.

Terminated Impurity / degradation Mylan Pharmaceuticals Inc. NDC 0378-5220-05 D-1557-2014
Class III · Low risk

Cardura XL

Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.

Terminated Impurity / degradation Pfizer Inc. NDC 0049-2710-30 D-1485-2014

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