Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA drug recalls in 2021

Every FDA drug recall initiated in 2021, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.

1,152 recalls, newest first.

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2021 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class I · High risk

1% Lidocaine HCl Injection

Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP

Terminated Labeling / mix-up Pfizer, INC NDC 0409-4279-16 D-0627-2021
Class I · High risk

0.5% Bupivacaine Hydrochloride Injection

Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP

Terminated Labeling / mix-up Pfizer, INC NDC 0409-1162-19 D-0626-2021
Class III · Low risk

Thiamine HCl Injection

Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.

Terminated Labeling / mix-up Mylan Institutional LLC D-0601-2021
Class II · Moderate risk

Sodium Chloride 0.9%

Temperature Abuse: Product exposed to temperature outside specified limits.

Terminated Temperature excursion Fresenius Medical Care Holdings, Inc. NDC 46163-0300-10 D-0603-2021
Class II · Moderate risk

Preferred Pharmaceuticals Inc.

CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.

Ongoing Nitrosamine impurity Preferred Pharmaceuticals, Inc. D-0385-2021

Recalls by year