B. Braun Medical Inc.
0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container
FDA Drug Recalls
Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.
Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.
Recently Announced (Pending Confirmation)
Provisional data.
These recalls were reported on FDA's own recall-announcement page but haven't yet been confirmed against openFDA's structured Drug Enforcement data. Public Health Trace is not affiliated with the FDA; this is not an official enforcement record until confirmed.
Ana Salazar Modela Tu Cuerpo Inc.
Lipofit Extreme 2.0 Fat Burner Dietary Supplement
Baxter International Inc.
0.9% Sodium Chloride Injection, USP, 500 mL VIAFLEX Plastic Container
Baxter International Inc.
70% Dextrose Injection, USP in 2000 mL VIAFLEX Plastic Container
Baxter International Inc.
Anticoagulant Sodium Citrate Solution USP, 250 mL VIAFLEX Plastic Container
Vitruvias Therapeutics, Inc
Thyroid Tablets, USP 30 mg
Optimal Balance Pharmacy
Glutathione Injection 200MG/ML (30ML), Multi-Dose Vial
B. Braun
Excel® Lactated Ringers Injection, 1000mL
Fresenius Kabi
Tyenne Injection 400 mg/20 mL vial
Fresenius Kabi
Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL
Victory Medical Center Pharmacy
Compounded Glutathione 200 mg/mL Multi-Dose Vials
Liebel-Flarsheim Company, LLC
OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial (Ioversol Injection 74% 350 mg iodine/ml)
American Regent, Inc. Animal Health
Adequan Canine Injection and Adequan i.m Injection for horses
American Regent, Inc.
Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL
Baxter International Inc.
Cefazolin in Dextrose Injection
Sunny Pharmtech, Inc.
Cyclophosphamide for Injection
Baxter International Inc.
Cefazolin in Dextrose Injection
Unique Pharmaceutical Laboratories
Cetirizine Hydrochloride Tablets USP 5 mg
Beekeeper’s Naturals
Saline Nasal Spray
BD
ChloraPrep Clear – 1 mL Applicators and ChloraPrep FREPP Clear 1.5 mL Applicators
Haleon
Gass-X Extra Strength Softgels 120 and 72ct
Sun Pharmaceutical Industries, Inc.
DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL
Pharmacal
Multi-symptom Treatment Cream & Skin Protectant Eczema Cream, 6oz tube
B. Braun Medical Inc.
Lactated Ringer's Injection, E7500, 1L
Blaine Labs, Inc.
Antiseptic wound care gel bottles and tubes
Aphreseller
Dietary supplement capsules marketed for treatment for gaining weight and stimulating appetite.
Amneal Pharmaceuticals LLC
Magnesium Sulfate in Water for Injection, USP, 4g/100mL, IV bag
Cardinal Health
Large Alcohol Prep Pads (70% isopropyl alcohol)
Anthony Trinh, 123Herbals LLC
Dietary supplement capsules marketed for relief of joint and body aches
Modern Warrior
Dietary supplement capsules marketed for metabolism moosting, improving brain function, and reducing cravings
Filters
Drug Recall Ongoing 2026 recordClass I
Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA, NDC 0019-1333-65.
- Reason
- Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
- Recall initiated
- July 31, 2026
- Reported by FDA
- August 19, 2026
- Distribution
- Distributed Nationwide in the US and Mexico.
Drug Recall Ongoing 2026 recordClass I
Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in sterile water for injection, VMC.
- Reason
- Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
- Recall initiated
- July 1, 2026
- Reported by FDA
- August 19, 2026
- Distribution
- USA Nationwide
Drug Recall Ongoing 2026 recordClass I
Kian Pee Wan Capsules, 30-count bottles
- Reason
- Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.
- Recall initiated
- March 21, 2026
- Reported by FDA
- August 19, 2026
- Distribution
- Product was sold to individual consumers via ebay third party seller.
Drug Recall Ongoing 2026 recordClass II
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
- Reason
- Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
- Recall initiated
- July 30, 2026
- Reported by FDA
- August 19, 2026
- Distribution
- Nationwide within the U.S
Drug Recall Ongoing 2026 recordClass II
CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC: 67172-999-01 UPC 6 78112 65920 3
- Reason
- Lack of assurance of sterility. The recall is due to potential contamination
- Recall initiated
- July 29, 2026
- Reported by FDA
- August 19, 2026
- Distribution
- Nationwide in the USA.
Drug Recall Ongoing 2026 recordClass II
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.
- Reason
- CGMP Deviations:Noted during FDA inspection
- Recall initiated
- August 3, 2026
- Reported by FDA
- August 19, 2026
- Distribution
- Distributed Nationwide in the USA
Drug Recall Ongoing 2026 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
- Reason
- CGMP Deviations:Noted during FDA inspection
- Recall initiated
- August 3, 2026
- Reported by FDA
- August 19, 2026
- Distribution
- Distributed Nationwide in the USA
Drug Recall Ongoing 2026 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.
- Reason
- CGMP Deviations:Noted during FDA inspection
- Recall initiated
- August 3, 2026
- Reported by FDA
- August 19, 2026
- Distribution
- Distributed Nationwide in the USA
Drug Recall Ongoing 2026 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.
- Reason
- CGMP Deviations:Noted during FDA inspection
- Recall initiated
- August 3, 2026
- Reported by FDA
- August 19, 2026
- Distribution
- Distributed Nationwide in the USA
Drug Recall Ongoing 2026 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
- Reason
- CGMP Deviations:Noted during FDA inspection
- Recall initiated
- August 3, 2026
- Reported by FDA
- August 19, 2026
- Distribution
- Distributed Nationwide in the USA
Drug Recall Ongoing 2026 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.
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Recall initiated
- July 29, 2026
- Reported by FDA
- August 19, 2026
- Distribution
- Nationwide within the U.S
Drug Recall Ongoing 2026 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
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Recall initiated
- July 29, 2026
- Reported by FDA
- August 19, 2026
- Distribution
- Nationwide within the U.S
Drug Recall Ongoing 2026 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
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Recall initiated
- July 29, 2026
- Reported by FDA
- August 19, 2026
- Distribution
- Nationwide within the U.S
Drug Recall Ongoing 2026 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
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Recall initiated
- July 29, 2026
- Reported by FDA
- August 19, 2026
- Distribution
- Nationwide within the U.S
Drug Recall Ongoing 2026 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
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Recall initiated
- July 29, 2026
- Reported by FDA
- August 19, 2026
- Distribution
- Nationwide within the U.S
Drug Recall Ongoing 2026 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
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Recall initiated
- July 29, 2026
- Reported by FDA
- August 19, 2026
- Distribution
- Nationwide within the U.S
Drug Recall Ongoing 2026 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
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Recall initiated
- July 29, 2026
- Reported by FDA
- August 19, 2026
- Distribution
- Nationwide within the U.S
Drug Recall Ongoing 2026 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
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Recall initiated
- July 29, 2026
- Reported by FDA
- August 19, 2026
- Distribution
- Nationwide within the U.S
Drug Recall Ongoing 2026 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
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Recall initiated
- July 29, 2026
- Reported by FDA
- August 19, 2026
- Distribution
- Nationwide within the U.S
Drug Recall Ongoing 2026 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
- Reason
- Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
- Recall initiated
- July 29, 2026
- Reported by FDA
- August 19, 2026
- Distribution
- Nationwide within the U.S
Data last updated:
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.
