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

638 recalls, newest first

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 I · High risk

Lidocaine HCl Injection

Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.

Terminated Particulate / foreign matter Hospira Inc. NDC 0409-2066-05 D-0020-2015
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
Class I · High risk

Marcaine (bupivacaine HCl)

Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.

Terminated Particulate / foreign matter Hospira Inc. NDC 0409-1560-29 D-0002-2015
Class II · Moderate risk

Brevibloc Premixed Injection

Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.

Terminated Particulate / foreign matter Baxter Healthcare Corp. NDC 10019-055-61 D-1413-2014
Class I · High risk

Soliris (eculizumab)

Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.

Terminated Particulate / foreign matter Alexion Pharmaceuticals, Inc. NDC 25682-001-01 D-1512-2014
Class II · Moderate risk

Mesalamine

Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product.

Terminated Particulate / foreign matter Cambrex Charles City Inc D-0447-2017
Class I · High risk

Coumadin for Injection

Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic cellulose fiber particles found in retain vials

Terminated Particulate / foreign matter Bristol-Meyers Squibb NDC 0590-0324-96 D-1595-2014
Class II · Moderate risk

Fosphenytoin Sodium Injection

Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.

Terminated Particulate / foreign matter Fresenius Kabi USA, LLC NDC 63323-403-10 D-1429-2014
Class II · Moderate risk

Fosphenytoin Sodium Injection

Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.

Terminated Particulate / foreign matter Fresenius Kabi USA, LLC NDC 63323-403-02 D-1428-2014
Class II · Moderate risk

Famotidine Injection 20 mg

Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.

Terminated Particulate / foreign matter Baxter Healthcare Corp. NDC 0338-5197-41 D-0293-2015
Class I · High risk

Marcaine (bupivacaine HCl)

Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.

Terminated Particulate / foreign matter Hospira Inc. NDC 0409-1559-10 D-1358-2014

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