FDA Recall
TerminatedTerminated: August 20, 2024Historical 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
OngoingHistorical 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
OngoingHistorical 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
OngoingHistorical 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
TerminatedTerminated: March 21, 2025Historical 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
TerminatedTerminated: July 5, 2024Historical recordClass I
Reser's Fine Foods, Inc.
- Product
- Item 404764, KIT EM CHICKEN STREET TACO DP EXPRESS MEAL 6/22…
- Reason
- Listeria monocytogenes. The recalled Cotija cheese was repackaged into finished wholesale and retail RTE products.
- Published
- March 27, 2024
- Distribution
- Distributed in CA, CT, FL, ID, IL, MD, M…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 5, 2024Historical recordClass I
Reser's Fine Foods, Inc.
- Product
- FCF Item 406957, Costco Item # 1744097, Club COSTCO SW Wrap…
- Reason
- Listeria monocytogenes. The recalled Cotija cheese was repackaged into finished wholesale and retail RTE products.
- Published
- March 27, 2024
- Distribution
- Distributed in CA, CT, FL, ID, IL, MD, M…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 5, 2024Historical recordClass I
Reser's Fine Foods, Inc.
- Product
- FCF Item 403953, HEB Poblano Caesar Dressing, 12oz. glass bo…
- Reason
- Listeria monocytogenes. The recalled Cotija cheese was repackaged into finished wholesale and retail RTE products.
- Published
- March 27, 2024
- Distribution
- Distributed in CA, CT, FL, ID, IL, MD, M…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 5, 2024Historical recordClass I
Reser's Fine Foods, Inc.
- Product
- FCF Item 403949, HEB Cilantro Cotija Dressing Perfect for Ta…
- Reason
- Listeria monocytogenes. The recalled Cotija cheese was repackaged into finished wholesale and retail RTE products.
- Published
- March 27, 2024
- Distribution
- Distributed in CA, CT, FL, ID, IL, MD, M…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 5, 2024Historical recordClass I
Reser's Fine Foods, Inc.
- Product
- Item # 407034, Don Pancho Fiesta 3 Pack Everything Sauce. E…
- Reason
- Listeria monocytogenes. The recalled Cotija cheese was repackaged into finished wholesale and retail RTE products.
- Published
- March 27, 2024
- Distribution
- Distributed in CA, CT, FL, ID, IL, MD, M…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 5, 2024Historical recordClass I
Reser's Fine Foods, Inc.
- Product
- FCF Item #404967, Costco Item #1506878, Cilantro Lime Crema,…
- Reason
- Listeria monocytogenes. The recalled Cotija cheese was repackaged into finished wholesale and retail RTE products.
- Published
- March 27, 2024
- Distribution
- Distributed in CA, CT, FL, ID, IL, MD, M…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 14, 2024Historical 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
TerminatedTerminated: April 8, 2024Historical 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
TerminatedTerminated: April 8, 2024Historical 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
TerminatedTerminated: April 8, 2024Historical 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
TerminatedTerminated: April 8, 2024Historical 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
TerminatedTerminated: April 8, 2024Historical 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
OngoingHistorical 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 →
FDA Recall
OngoingHistorical recordClass II
Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-098-44
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 →
FDA Recall
TerminatedTerminated: December 22, 2025Historical recordClass II
Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, Carton NDC 55150-470-06, Vial NDC 55150-470-01.
by Eugia US LLC
- Reason
- Failed Stability Specification: Water determination was found not complying with specification.
- 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.
Read the full medical disclaimer.