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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 101–120 of 1,000 recalls

Class IIOngoing

Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17.

ACCORD HEALTHCARE, INC.

Subpotent Drug

August 6, 2026 · DrugView details →

Class IIOngoing

Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-9647-12.

Baxter Healthcare Corporation

CGMP Deviations

August 6, 2026 · DrugView details →

Class IIOngoing

Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-995-24.

Baxter Healthcare Corporation

CGMP Deviations

August 6, 2026 · DrugView details →

Class IIOngoing

Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3552-48.

Baxter Healthcare Corporation

CGMP Deviations

August 6, 2026 · DrugView details →

Class IIOngoing

Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-9549-50.

Baxter Healthcare Corporation

CGMP Deviations

August 6, 2026 · DrugView details →

Class IIOngoing

Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3.

Zydus Pharmaceuticals (USA) Inc

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

August 5, 2026 · DrugView details →

Class IIOngoing

Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34

Novartis Pharmaceuticals Corporation

Failed Dissolution Specifications

August 4, 2026 · DrugView details →

Class IIOngoing

SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-05

Shoolin Pharma Chem LLP

CGMP Deviations:Noted during FDA inspection

August 3, 2026 · DrugView details →

Class IIOngoing

Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04.

Lupin Pharmaceuticals Inc.

Failed content uniformity specifications.

August 3, 2026 · DrugView details →

Class IIOngoing

TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 1715996-29-5), NDC 85702-002-02.

Shoolin Pharma Chem LLP

CGMP Deviations:Noted during FDA inspection

August 3, 2026 · DrugView details →

Class IIOngoing

Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.

SUN PHARMACEUTICAL INDUSTRIES INC

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

August 3, 2026 · DrugView details →

Class IIOngoing

TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-002-04.

Shoolin Pharma Chem LLP

CGMP Deviations:Noted during FDA inspection

August 3, 2026 · DrugView details →

Class IIOngoing

SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-08.

Shoolin Pharma Chem LLP

CGMP Deviations:Noted during FDA inspection

August 3, 2026 · DrugView details →

Class IIOngoing

TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-001-08

Shoolin Pharma Chem LLP

CGMP Deviations:Noted during FDA inspection

August 3, 2026 · DrugView details →

Class IIOngoing

CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51

Heritage Pharmaceuticals Inc

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

July 30, 2026 · DrugView details →

Class IIOngoing

SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-721-01

Apollo Care, LLC

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

July 29, 2026 · DrugView details →

Class IIOngoing

SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-495-05

Apollo Care, LLC

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

July 29, 2026 · DrugView details →

Class IIOngoing

PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2453-1

Shilpa Medicare Limited

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

July 29, 2026 · DrugView details →

Class IIOngoing

SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-811-02

Apollo Care, LLC

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

July 29, 2026 · DrugView details →

Class IIOngoing

SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-711-02

Apollo Care, LLC

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

July 29, 2026 · DrugView details →

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