Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

621 recalls · Class II, newest first

Class II · Moderate risk

biotene PBF Toothpaste

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

Terminated Particulate / foreign matter GlaxoSmithkline Consmer Healthcare NDC 0135-0559-01 D-1320-2015
Class II · Moderate risk

biotene Gentle Mint Gel

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

Terminated Particulate / foreign matter GlaxoSmithkline Consmer Healthcare NDC 0135-0488-01 D-1317-2015
Class II · Moderate risk

NEXIUM¿ (esomeprazole magnesium)

Presence of Foreign Tablets/Capsules: Confimed customer compliant by a retail pharmacist that an unopened bottle labeled as NEXIUM¿ capsules contained 60 SEROQUEL¿ XR tablets.

Terminated Particulate / foreign matter AstraZeneca Pharmaceuticals LP NDC 00186-5020-31 D-1141-2015
Class II · Moderate risk

Mafenide Acetate

Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene

Terminated Particulate / foreign matter Par Pharmaceutical Inc. NDC 49884-902-52 D-0393-2015
Class II · Moderate risk

Propofol Injectable Emulsion

Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.

Terminated Particulate / foreign matter Hospira Inc. NDC 0409-4699-30 D-0381-2015
Class II · Moderate risk

HydrALAZINE Hydrochloride Tablets

Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small aluminum particles.

Terminated Particulate / foreign matter Par Pharmaceutical Inc. D-0332-2015
Class II · Moderate risk

Bupivacaine HCl Inj.

Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial.

Terminated Particulate / foreign matter Hospira Inc. NDC 0409-1162-02 D-1588-2014
Class II · Moderate risk

ProSol - sulfite-free

Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).

Terminated Particulate / foreign matter Baxter Healthcare Corp NDC 0338-0499-06 D-1542-2014
Class II · Moderate risk

Alprazolam Tablets

Presence of Foreign Substance; tablets may contain stainless steel metal particulates

Terminated Particulate / foreign matter Mckesson Packaging Services NDC 63739-644-10 D-1515-2014
Class II · Moderate risk

Alprazolam Tablets

Presence of Foreign Substance; tablets may contain stainless steel metal particulates

Terminated Particulate / foreign matter Sandoz Incorporated NDC 0781-1061-10 D-1509-2014

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