Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts

FDA Drug Recalls

31 recalls · Class I, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2013 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class I · High risk

Lidocaine HCl Injection

Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.

Terminated Particulate / foreign matter Hospira Inc. NDC 0409-2066-05 D-1278-2014
Class I · High risk

Hyperlyte CR

Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

Terminated Particulate / foreign matter B. Braun Medical Inc NDC 0264-1943-20 D-1275-2014
Class I · High risk

ProcalAmine

Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

Terminated Particulate / foreign matter B. Braun Medical Inc NDC 0264-1915-07 D-1274-2014
Class I · High risk

TrophAmine

Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

Terminated Particulate / foreign matter B. Braun Medical Inc NDC 0264-9341-55 D-1273-2014
Class I · High risk

15% Amino Acids Injection PBP Glass

Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

Terminated Particulate / foreign matter B. Braun Medical Inc NDC 0264-3200-55 D-1272-2014
Class I · High risk

6.9% FreAmine HBC

Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

Terminated Particulate / foreign matter B. Braun Medical Inc NDC 0264-9350-55 D-1271-2014
Class I · High risk

0.9 % Sodium Chloride Injection USP

Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

Terminated Particulate / foreign matter B. Braun Medical Inc NDC 0264-4000-55 D-1270-2014
Class I · High risk

0.9% Sodium Chloride Injection

Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag

Terminated Particulate / foreign matter Baxter Healthcare Corp. NDC 0338-0049-31 D-1163-2014
Class I · High risk

5% Dextrose Injection

Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag

Terminated Particulate / foreign matter Baxter Healthcare Corp. NDC 0338-0017-38 D-1162-2014
Class I · High risk

Soliris (eculizumab)

Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.

Terminated Particulate / foreign matter Alexion Pharmaceuticals, Inc. NDC 25682-001-01 D-1049-2014
Class I · High risk

Marcaine (bupivacaine HCl)

Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.

Terminated Particulate / foreign matter Hospira Inc. NDC 0409-1559-30 D-1161-2014
Class I · High risk

Aminosyn II

Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.

Terminated Particulate / foreign matter Hospira Inc. NDC 0409-4164-03 D-461-2014

Recalls by year