FDA Recall
Terminated
Historical recordClass II
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58
by Fresenius Kabi Compounding, LLC
- Reason
- cGMP violations
- Published
- October 30, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58
by Fresenius Kabi Compounding, LLC
- Reason
- cGMP violations
- Published
- October 30, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58
by Fresenius Kabi Compounding, LLC
- Reason
- cGMP violations
- Published
- October 30, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58
by Fresenius Kabi Compounding, LLC
- Reason
- cGMP violations
- Published
- October 30, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58
by Fresenius Kabi Compounding, LLC
- Reason
- cGMP violations
- Published
- October 30, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58
by Fresenius Kabi Compounding, LLC
- Reason
- cGMP violations
- Published
- October 30, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58
by Fresenius Kabi Compounding, LLC
- Reason
- CGMP violations
- Published
- October 30, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Distributed by: Rugby Laboratories, Indianapolis, IN 46268. Made in China. NDC: 0536-1271-80
by Zhejiang Jingwei Pharmaceutical Co., Ltd.
- Reason
- Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.
- Published
- October 23, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.
by Bionpharma Inc.
- Reason
- Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
- Published
- October 23, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad 382 213, India. Mfg. Lic. No.: G/28/1336, NDC 16729-288-38
by ACCORD HEALTHCARE, INC.
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- October 23, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.
by Breckenridge Pharmaceutical, Inc
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Published
- October 23, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Gorilla Mind LLC
- Product
- Gorilla Mind Rauwolscine Dietary Supplement, Suppress Appeti…
- Reason
- Product was recalled due to the potential for contamination with Salmonella
- Published
- October 23, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Hydration Labs Inc. dba Bevi
- Product
- Flavor#115 Electrolytes, Net Contents 3.78L, #740-0115, GTIN…
- Reason
- Product is labeled as electrolytes but is actually caffeine
- Published
- October 23, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Walmart Inc
- Product
- Great Value Cherry Mixed Fruit, 4 oz, 4 Count and 12 count p…
- Reason
- FD&C Red No 3 was not declared as an ingredient.
- Published
- October 23, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Walmart Inc
- Product
- Great Value Diced Peaches, Mandarin Segments, & Cherry Mixed…
- Reason
- FD&C Red No 3 was not declared as an ingredient.
- Published
- October 23, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/bottle, 29 g net fill weight, Distr. by Hikma Specialty USA Inc., Columbus, OH 43328, hikma, Glenmark Specialty SA. NDC 59467-700-27.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Defective Delivery System: The dip tube is clogged causing the spray not to work.
- Published
- October 9, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2
by Gilead Sciences, Inc.
- Reason
- Presence of Particulate Matter: Presence of glass particle.
- Published
- October 9, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199
by Supercore Products Group Inc.
- Reason
- Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
- Published
- October 9, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
by Supercore Products Group Inc.
- Reason
- Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
- Published
- October 9, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 gm Tube, NDC 68462-0455-47; c) 100 gm Tube, NDC 68462-0455-94, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Defective Container: Firm received complaints of broken tube at the seal.
- Published
- October 9, 2024
- 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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