Independent register of U.S. FDA drug recalls · updated Oct 13, 2026
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FDA Drug Recalls

14,806 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 II · Moderate risk

Blephamide

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Terminated Particulate / foreign matter Allergan Sales, LLC NDC 0023-0313-04 D-1820-2015
Class II · Moderate risk

FML (fluorometholone ophthalmic ointment)

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Terminated Particulate / foreign matter Allergan Sales, LLC NDC 0023-0316-04 D-1819-2015
Class II · Moderate risk

Refresh P.M.

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Terminated Particulate / foreign matter Allergan Sales, LLC NDC 0023-0240-04 D-1818-2015
Class II · Moderate risk

Refresh Lacri-Lube

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Terminated Particulate / foreign matter Allergan Sales, LLC NDC 0023-0312-04 D-1817-2015
Class I · High risk

Xcellerator

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

Terminated Unapproved drug Novacare, LLC D-0973-2016
Class I · High risk

TruTrim (product not labeled)

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

Terminated Unapproved drug Novacare, LLC D-0967-2016
Class III · Low risk

Lamivudine Oral Solution

Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17).

Terminated Labeling / mix-up Silarx Pharmaceutical, Inc. NDC 54838-0566-70 D-1416-2015

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