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

Gatifloxacin Ophthalmic Solution

Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.

Terminated Stability / shelf life Lupin Pharmaceuticals Inc. NDC 68180-435-01 D-0091-2022
Class III · Low risk

AERO Tab PAIN RELIEVER

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Terminated Stability / shelf life Ultra Seal Corporation D-0073-2022
Class III · Low risk

Vica-Cet BACK PAIN RELIEF

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Terminated Stability / shelf life Ultra Seal Corporation D-0071-2022
Class III · Low risk

PainAway II

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Terminated Stability / shelf life Ultra Seal Corporation D-0070-2022
Class III · Low risk

Cetirizine hydrochloride

Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.

Terminated Labeling / mix-up A-S Medication Solutions LLC. D-0096-2022
Class III · Low risk

Butalbital

Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label

Ongoing Labeling / mix-up Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals D-0257-2022
Class III · Low risk

Butalbital

Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label

Ongoing Labeling / mix-up Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals D-0256-2022
Class III · Low risk

Hydroquinone

Subpotency: one product for active ingredient assay and another one for preservative assay

Terminated Wrong potency / content Monarch PCM, LLC NDC 69367-174-01 D-0818-2021
Class III · Low risk

Sodium Sulfacetamide

Subpotency: one product for active ingredient assay and another one for preservative assay

Terminated Wrong potency / content Monarch PCM, LLC NDC 42808-103-06 D-0817-2021

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