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FDA Drug Recalls

404 recalls · Class II, newest first

Class II · Moderate risk Ongoing Aug 5, 2026

Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda…

Reason CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.

Zydus Pharmaceuticals (USA) Inc NDC 70710-1159-3 D-0745-2026

Class II · Moderate risk Ongoing Aug 4, 2026

Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834…

Reason Failed Dissolution Specifications

Novartis Pharmaceuticals Corporation NDC 0078-0359-34 D-0746-2026

Class II · Moderate risk Ongoing Aug 3, 2026

SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP…

Reason CGMP Deviations:Noted during FDA inspection

Shoolin Pharma Chem LLP NDC 85702-001-08 D-0763-2026

Class II · Moderate risk Ongoing Aug 3, 2026

TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no…

Reason CGMP Deviations:Noted during FDA inspection

Shoolin Pharma Chem LLP NDC 85702-001-08 D-0762-2026

Class II · Moderate risk Ongoing Aug 3, 2026

TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey…

Reason CGMP Deviations:Noted during FDA inspection

Shoolin Pharma Chem LLP NDC 85702-002-04 D-0761-2026

Class II · Moderate risk Ongoing Aug 3, 2026

TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey…

Reason CGMP Deviations:Noted during FDA inspection

Shoolin Pharma Chem LLP NDC 85702-002-02 D-0760-2026

Class II · Moderate risk Ongoing Aug 3, 2026

SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP…

Reason CGMP Deviations:Noted during FDA inspection

Shoolin Pharma Chem LLP NDC 85702-001-05 D-0759-2026

Class II · Moderate risk Ongoing Jul 30, 2026

CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals…

Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.

Heritage Pharmaceuticals Inc NDC 23155-603-51 D-0768-2026

Class II · Moderate risk Ongoing Jul 29, 2026

CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY…

Reason Lack of assurance of sterility. The recall is due to potential contamination

Prestige Brands Holdings D-0766-2026

Class II · Moderate risk Ongoing Jul 29, 2026

SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO…

Reason Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Apollo Care, LLC NDC 71170-724-04 D-0757-2026

Class II · Moderate risk Ongoing Jul 29, 2026

SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO…

Reason Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Apollo Care, LLC NDC 71170-722-02 D-0756-2026

Class II · Moderate risk Ongoing Jul 29, 2026

SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only…

Reason Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Apollo Care, LLC NDC 71170-721-01 D-0755-2026

Class II · Moderate risk Ongoing Jul 29, 2026

SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO…

Reason Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Apollo Care, LLC NDC 71170-712-03 D-0754-2026

Class II · Moderate risk Ongoing Jul 29, 2026

SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only…

Reason Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Apollo Care, LLC NDC 71170-711-02 D-0753-2026

Class II · Moderate risk Ongoing Jul 29, 2026

SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave…

Reason Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Apollo Care, LLC NDC 71170-810-01 D-0752-2026

Class II · Moderate risk Ongoing Jul 29, 2026

SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct…

Reason Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Apollo Care, LLC NDC 71170-822-02 D-0751-2026

Class II · Moderate risk Ongoing Jul 29, 2026

SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave…

Reason Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Apollo Care, LLC NDC 71170-812-03 D-0750-2026

Class II · Moderate risk Ongoing Jul 29, 2026

SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801…

Reason Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Apollo Care, LLC NDC 71170-821-01 D-0749-2026

Class II · Moderate risk Ongoing Jul 29, 2026

SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801…

Reason Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Apollo Care, LLC NDC 71170-811-02 D-0748-2026

Class II · Moderate risk Ongoing Jul 29, 2026

SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave…

Reason Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

Apollo Care, LLC NDC 71170-495-05 D-0747-2026

Class II · Moderate risk Ongoing Jul 23, 2026

Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279…

Reason shortfill; reports of empty capsules.

Aurobindo Pharma USA Inc NDC 59651-719-99 D-0733-2026

Class II · Moderate risk Ongoing Jul 23, 2026

Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood…

Reason CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.

Glenmark Pharmaceuticals Inc., USA NDC 68462-626-52 D-0731-2026

Class II · Moderate risk Ongoing Jul 22, 2026

Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro Labs…

Reason Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.

Micro Labs USA INC NDC 42571-147-26 D-0730-2026

Class II · Moderate risk Ongoing Jul 16, 2026

Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile…

Reason Presence of Particulate Matter: Hair was found in products

Fresenius Kabi USA, LLC D-0729-2026

Class II · Moderate risk Ongoing Jul 16, 2026

Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile…

Reason Presence of Particulate Matter: Hair was found in products

Fresenius Kabi USA, LLC D-0728-2026