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

FDA Drug Recalls

21 recalls, newest first

Unclassified

0.9% Sodium Chloride Injection

Product Mix-up: 0.9% SODIUM CHLORIDE Injection, USP may potentially contain the overwrap with labeling indicating it to be 0.9% SODIUM CHLORIDE Injection, USP but the actual product within the overwrap may be POTASSIUM CHLORIDE Inj.10 mEq

Ongoing Labeling / mix-up Otsuka ICU Medical LLC NDC 0990-7984-23 Recall number pending
Class II · Moderate risk

fentaNYL Citrate

Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).

Ongoing Labeling / mix-up OurPharma LLC NDC 73013-1013-01 D-0864-2026
Class I · High risk

Morphine Sulfate Injection

Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.

Ongoing Labeling / mix-up Fresenius Kabi USA, LLC D-0788-2026
Class III · Low risk

Lidolog Kit

Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

Ongoing Labeling / mix-up Asclemed USA Inc. D-0713-2026
Class II · Moderate risk

Dextroamphetamine Saccharate

Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.

Ongoing Labeling / mix-up Lannett Company Inc. D-0660-2026
Class II · Moderate risk

Perampanel CIII Tablets

Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.

Ongoing Labeling / mix-up Sun Pharmaceutical Industries INC NDC 51672-4206-6 D-0628-2026
Class III · Low risk

Focalin XR

Labeling: Incorrect or Missing Lot and/or Exp Date

Ongoing Labeling / mix-up Sandoz Inc D-0608-2026
Class II · Moderate risk

Aripiprazole Tablets USP

Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.

Ongoing Labeling / mix-up Ajanta Pharma USA Inc NDC 27241-056-03 D-0594-2026
Class II · Moderate risk

Xyvona (levorphanol tartrate tablets)

Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona

Ongoing Labeling / mix-up Sun Pharmaceutical Industries INC NDC 72245-058-10 D-0599-2026
Class II · Moderate risk

Xyvona (levorphanol tartrate tablets)

Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona

Ongoing Labeling / mix-up Sun Pharmaceutical Industries INC NDC 72245-762-10 D-0598-2026
Class III · Low risk

Lidocaine HCl Injection

Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

Ongoing Labeling / mix-up Eugia US LLC D-0552-2026
Class II · Moderate risk

Gas-X

Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.

Ongoing Labeling / mix-up Haleon US Holdings LLC D-0542-2026
Class II · Moderate risk

Atomoxetine Capsules HCL

Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.

Ongoing Labeling / mix-up Safecor Health, LLC D-0538-2026
Class III · Low risk

Premier

Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.

Ongoing Labeling / mix-up Premier Dental Products Co NDC 48783-112-08 D-0490-2026
Class I · High risk

Magnesium Sulfate in Water for Injection

Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.

Ongoing Labeling / mix-up Amneal Pharmaceuticals, LLC NDC 70121-1720-3 D-0478-2026
Class III · Low risk

Eptifibatide Injection

Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.

Ongoing Labeling / mix-up Slate Run Pharmaceuticals D-0343-2026
Class III · Low risk

Doxazosin Tablets

Tablets/Capsules Imprinted with Wrong ID

Ongoing Labeling / mix-up Unichem Pharmaceuticals USA Inc. NDC 29300-353-10 D-0306-2026
Class II · Moderate risk

methylprednisolone tablets

Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.

Ongoing Labeling / mix-up Greenstone Llc NDC 59762-4440-2 D-0299-2026

Recalls by year