FDA Recall
Terminated
Historical recordClass II
fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0222-30 BAR code 70004022230
by SCA Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- April 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, 877.550.5059, NDC 70004-0229-40 BAR code 70004022940
by SCA Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- April 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095; NDC 70004-0541-35, Bar Code 70004054135
by SCA Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- April 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Roland Foods, LLC.
- Product
- Roland Tahini; 100% Ground Sesame Seeds; Net WT. 16 OZ. (1 L…
- Reason
- Product may be contaminated with Salmonella.
- Published
- April 3, 2024
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Nordic Naturals, Inc.
- Product
- Nordic Naturals Baby s Vitamin D3 liquid, 400 IU (10 mcg) D3…
- Reason
- Elevated levels of vitamin D3
- Published
- April 3, 2024
- Distribution
- Products are distributed to 79 consignee…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
John B. Sanfilippo & Son Inc.
- Product
- Great Value Honey Roasted Cashews, 8.25oz. plastic can, UPC…
- Reason
- undeclared milk and coconut
- Published
- April 3, 2024
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
WS Global Inc
- Product
- Himalayan Pain Relief Tea for Gout and Hangover
- Reason
- Contains undeclared drugs Diclofenac and Dexamethasone Acetate
- Published
- April 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York, New York 10001.
by Super Chill Products
- Reason
- Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
- Published
- March 27, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01
by Hikma Pharmaceuticals USA Inc.
- Reason
- The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
- Published
- March 27, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, NDC 55150-183-11
by Eugia US LLC
- Reason
- Failed Impurities/Degradation Specifications: Out of specification for organic impurities
- Published
- March 27, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10
by Eugia US LLC
- Reason
- Failed Impurities/Degradation Specifications: Out of specification for organic impurities
- Published
- March 27, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-201-20
by Novitium Pharma LLC
- Reason
- Cross Contamination with Other Products:(mycophenolate mofetil).
- Published
- March 27, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Bob Evans Farms (BEF)
- Product
- Bob Evan's Original Mash Potato 2lbs (32 oz) packaged in bla…
- Reason
- Potential for foreign material - Red Plastic
- Published
- March 27, 2024
- Distribution
- Connecticut, Illinois, Massachusetts, Ne…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Stonewall Kitchen, LLC
- Product
- Stonewall Kitchen Cinnamon Sugar Doughnut Mix; Gluten Free;…
- Reason
- Product contains undeclared wheat.
- Published
- March 27, 2024
- Distribution
- MA, WY, MT, ND, IA, NC, NM, ME, NJ, VT,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Dole Fresh Vegetables Inc
- Product
- Marketside Chopped Salad Kit Bacon Crunch UPC 681131305440
- Reason
- Product has the potential to be contaminated with Listeria monocytogenes.
- Published
- March 27, 2024
- Distribution
- U.S . distribution to the following: AL,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Dole Fresh Vegetables Inc
- Product
- Dole Premium Kit Endless Summer UPC 71430010730
- Reason
- Product has the potential to be contaminated with Listeria monocytogenes.
- Published
- March 27, 2024
- Distribution
- U.S . distribution to the following: AL,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Dole Fresh Vegetables Inc
- Product
- Dole Cajun Ranch Chopped Kit UPC 71430002063
- Reason
- Product has the potential to be contaminated with Listeria monocytogenes.
- Published
- March 27, 2024
- Distribution
- U.S . distribution to the following: AL,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Dole Fresh Vegetables Inc
- Product
- Dole Premium Kit Southwest Salad UPC 71430017012
- Reason
- Product has the potential to be contaminated with Listeria monocytogenes.
- Published
- March 27, 2024
- Distribution
- U.S . distribution to the following: AL,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Dole Fresh Vegetables Inc
- Product
- Dole Chopped Kit Avocado Ranch UPC 71430000915
- Reason
- Product has the potential to be contaminated with Listeria monocytogenes.
- Published
- March 27, 2024
- Distribution
- U.S . distribution to the following: AL,…
View recall →
FDA Recall
Ongoing
Historical recordClass II
Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, 25 sachets per box, Made in the Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-097-12
by Global Corporation
- Reason
- Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
- Published
- March 20, 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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