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

Every FDA drug recall initiated in 2026, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.

563 recalls, newest first.

Class I · High risk

Glutathione 200 mg/mL

Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

Ongoing Microbial contamination Optimal Balance Pharmacy D-0851-2026
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 II · Moderate risk

Diovan (valsartan)

Failed Dissolution Specifications

Ongoing Dissolution failure Novartis Pharmaceuticals Corporation NDC 0078-0359-34 D-0746-2026
Class II · Moderate risk

Carbamazepine Tablets

CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing

Ongoing cGMP deviation Sun Pharmaceutical Industries INC NDC 51672-4005-3 D-0770-2026
Class II · Moderate risk

Sildenafil Citrate USP

CGMP Deviations:Noted during FDA inspection

Ongoing cGMP deviation Shoolin Pharma Chem LLP NDC 85702-001-08 D-0763-2026
Class II · Moderate risk

Tadalafil USP

CGMP Deviations:Noted during FDA inspection

Ongoing cGMP deviation Shoolin Pharma Chem LLP NDC 85702-001-08 D-0762-2026
Class II · Moderate risk

Tadalafil USP

CGMP Deviations:Noted during FDA inspection

Ongoing cGMP deviation Shoolin Pharma Chem LLP NDC 85702-002-04 D-0761-2026
Class II · Moderate risk

Tadalafil USP

CGMP Deviations:Noted during FDA inspection

Ongoing cGMP deviation Shoolin Pharma Chem LLP NDC 85702-002-02 D-0760-2026
Class II · Moderate risk

Sildenafil Citrate USP

CGMP Deviations:Noted during FDA inspection

Ongoing cGMP deviation Shoolin Pharma Chem LLP NDC 85702-001-05 D-0759-2026
Class II · Moderate risk

Pemrydi Rtu

Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials

Ongoing Failed specification Shilpa Medicare Limited D-0765-2026
Class II · Moderate risk

Pemrydi Rtu

Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials

Ongoing Failed specification Shilpa Medicare Limited D-0764-2026

Recalls by year