FDA Recall
Ongoing2026 recordClass II
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
by Shoolin Pharma Chem LLP
- Reason
- CGMP Deviations:Noted during FDA inspection
- Published
- August 19, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
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.
by Shoolin Pharma Chem LLP
- Reason
- CGMP Deviations:Noted during FDA inspection
- Published
- August 19, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
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.
by Shoolin Pharma Chem LLP
- Reason
- CGMP Deviations:Noted during FDA inspection
- Published
- August 19, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
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
by Shoolin Pharma Chem LLP
- Reason
- CGMP Deviations:Noted during FDA inspection
- Published
- August 19, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-724-04.
by Apollo Care, LLC
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Published
- August 19, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-722-02
by Apollo Care, LLC
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Published
- August 19, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
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
by Apollo Care, LLC
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Published
- August 19, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (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 71170-712-03
by Apollo Care, LLC
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Published
- August 19, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
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
by Apollo Care, LLC
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Published
- August 19, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-810-01
by Apollo Care, LLC
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Published
- August 19, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-822-02
by Apollo Care, LLC
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Published
- August 19, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-812-03
by Apollo Care, LLC
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Published
- August 19, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
SEMAGLUTIDE 6.75mg (4.5 mg/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 71170-821-01
by Apollo Care, LLC
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Published
- August 19, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
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
by Apollo Care, LLC
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Published
- August 19, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
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
by Apollo Care, LLC
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Published
- August 19, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
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
by Novartis Pharmaceuticals Corporation
- Reason
- Failed Dissolution Specifications
- Published
- August 19, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
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.
by Zydus Pharmaceuticals (USA) Inc
- Reason
- CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
- Published
- August 12, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass I
Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1
by Sunny Pharmtech Inc.
- Reason
- Presence of Particulate Matter; identified as stainless steel
- Published
- August 12, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass I
Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8112-1
by Sunny Pharmtech Inc.
- Reason
- Presence of Particulate Matter; identified as stainless steel
- Published
- August 12, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99
by Aurobindo Pharma USA Inc
- Reason
- shortfill; reports of empty capsules.
- Published
- August 12, 2026
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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