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

18,003 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

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