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

CVS Pharmacy

Superpotent Drug: Out Of Specification (OOS) result for Assay.

Terminated Wrong potency / content Ohm Laboratories, Inc. D-0023-2016
Class III · Low risk

Phentermine Hydrochloride Capsules

Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station

Terminated Impurity / degradation PD-Rx Pharmaceuticals, Inc. NDC 55289-791-07 D-0574-2016
Class III · Low risk

Allopurinol Tablets

Failed Tablet/Capsule Specifications; report of oversized and discolored tablets

Terminated Failed specification Qualitest Pharmaceuticals NDC 0603-2116-28 D-1405-2015
Class III · Low risk

buPROPion Hydrochloride Extended-¿release Tablets USP

Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.

Terminated Dissolution failure Sun Pharma Global Fze NDC 47335-738-86 D-1345-2015
Class III · Low risk

Imipramine HCl Tablets

Chemical Contamination; benzophenone leached from the product label varnish

Terminated Chemical / undeclared Mutual Pharmaceutical Company, Inc. NDC 54738-914-01 D-1425-2015
Class III · Low risk

Imipramine HCl Tablets

Chemical Contamination; benzophenone leached from the product label varnish

Terminated Chemical / undeclared Mutual Pharmaceutical Company, Inc. NDC 54738-913-01 D-1424-2015
Class III · Low risk

Imipramine HCl Tablets

Chemical Contamination; benzophenone leached from the product label varnish

Terminated Chemical / undeclared Mutual Pharmaceutical Company, Inc. NDC 54738-912-01 D-1423-2015
Class III · Low risk

Phentermine Hydrochloride Capsules

Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station

Terminated Impurity / degradation KVK-Tech, Inc. NDC 10702-0026-01 D-1371-2015
Class III · Low risk

Intermezzo

Failed dissolution specifications

Terminated Dissolution failure Purdue Pharma L.P. NDC 59011-265-30 D-1278-2015

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