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

362 recalls · Class III, newest first

Class III · Low risk

Pluvicto 1

Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date

Terminated Labeling / mix-up Advanced Accelerator Applications USA, Inc. NDC 69488-010-61 D-1085-2023
Class III · Low risk

0.9% Sodium Chloride Injection USP

Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.

Terminated Labeling / mix-up B. Braun Medical Inc. NDC 0264-5802-00 D-1083-2023
Class III · Low risk

Methylprednisolone Acetate Injectable Suspension

Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.

Terminated Labeling / mix-up Amneal Pharmaceuticals of New York, LLC NDC 70121-1574-01 D-0756-2023
Class III · Low risk

Gabapentin Tablets

Product mixup: one foreign tablet found in product.

Terminated Labeling / mix-up The Harvard Drug Group NDC 0904-6823-61 D-0570-2023
Class III · Low risk

Lidocaine Patch 5%

Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.

Ongoing Labeling / mix-up Bryant Ranch Prepack, Inc. D-0556-2023
Class III · Low risk

Bevacizumab 2.5 mg/0.1 mL

Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.

Terminated Labeling / mix-up Pine Pharmaceuticals, LLC NDC 69194-0458-1 D-0531-2023
Class III · Low risk

MEKTOVI (binimetinib)

Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.

Ongoing Labeling / mix-up Pfizer Inc. D-0532-2023
Class III · Low risk

Levofloxacin Tablets

Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.

Terminated Labeling / mix-up Macleods Pharma USA, INC NDC 33342-022-08 D-0162-2023
Class III · Low risk

Phenytoin Sodium Injection

Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.

Terminated Labeling / mix-up Acella Pharmaceuticals, LLC NDC 42192-614-05 D-0070-2023
Class III · Low risk

Phenytoin Sodium Injection

Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.

Terminated Labeling / mix-up Acella Pharmaceuticals, LLC NDC 42192-614-02 D-0069-2023
Class III · Low risk

Clonidine Hydrochloride Tablets

Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,

Terminated Labeling / mix-up Unichem Pharmaceuticals USA INC NDC 29300-137-01 D-1541-2022
Class III · Low risk

Nighttime Sleep-Aid

Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.

Terminated Labeling / mix-up LNK International, Inc. D-1472-2022
Class III · Low risk

Tivicay (dolutegravir)

Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.

Terminated Labeling / mix-up GlaxoSmithKline LLC NDC 49702-228-13 D-0896-2022

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