Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class III drug recalls - low risk

Class III means the product is unlikely to cause harm but violates FDA labeling or manufacturing rules. These are the recalls you rarely hear about; pharmacies usually just swap the affected lot.

1,716 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 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
Class III · Low risk

Foradil Aerolizer

Failed Stability Specification; out of specification result for particle size distribution during stability testing

Terminated Stability / shelf life Novartis Pharmaceuticals Corp. NDC 0085-1401-01 D-1387-2014
Class III · Low risk

Vasotec (enalapril maleate)

Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.

Terminated Labeling / mix-up Valeant Pharmaceuticals North America LLC NDC 0187-0140-90 D-0019-2015
Class III · Low risk

Oasis TEARS

Labeling: Missing Label; The label on the immediate bottle is missing.

Terminated Labeling / mix-up Oasis Medical Inc D-1347-2014
Class III · Low risk

Triveen - PRx RNF Capsules

Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 micrograms) on the Supplement Facts panel, however, the formulation of this product does not contain Vitamin B12.

Terminated Labeling / mix-up Trigen Laboratories, Inc. NDC 13811-558-30 D-1544-2014
Class III · Low risk

Wockhardt Metoprolol Succinate

Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.

Terminated Dissolution failure Wockhardt Usa Inc. NDC 64679-735-02 D-0304-2015

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