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
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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
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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 III
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Inc., Atlanta, 1750 Corp Dr. Ste 725, Norcross, GA 30093 (844) 903-6418
by Central Admixture Pharmacy Services Inc
- Reason
- Incorrect Product Formulation
- Published
- August 12, 2026
- Distribution
- GA only
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 →
FDA Recall
🇺🇸 United States
Ongoing2026 recordClass II
PT Organics Limited
- Product
- Pumpkin Tree Peter Rabbit Organics Banana & Strawberry fruit…
- Reason
- Possible foreign object (thin, soft plastic strands).
- Published
- August 12, 2026
- Distribution
- Distributed in AL, AZ, CA, CO, GA, IA, I…
View recall →
FDA Recall
🇺🇸 United States
Ongoing2026 recordClass I
AKKARCO LLC
- Product
- Ashfiat Alharamain Energy Support 250ml/8fl. oz.
- Reason
- Undeclared tadalafil
- Published
- August 12, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing2026 recordClass I
M.G. Foods, Inc.
- Product
- Spicy Breakfast Burrito sold under the following brand names…
- Reason
- Undeclared Soy. The firm received complaints of sausage in the burritos. Upon review the firm discovered the sausage contains soy which is not listed on the label.
- Published
- August 12, 2026
- Distribution
- Product was shipped to the following sta…
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FDA Recall
Ongoing2026 recordClass III
Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.
by Ascend Laboratories, LLC
- Reason
- Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
- Published
- August 5, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass III
Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.
by Ascend Laboratories, LLC
- Reason
- Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
- Published
- August 5, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass III
Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.
by Ascend Laboratories, LLC
- Reason
- Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
- Published
- August 5, 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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