FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
The Great Spirits Baking Company, LLC
- Product
- Jack Daniels Tennessee Whiskey Cake - Pecan - Net Wt 8 OZ (2…
- Reason
- Cakes are potentially moldy prior to their "best by" date.
- Published
- November 6, 2019
- Distribution
- Distributed to retail stores in CA, NC,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
The Great Spirits Baking Company, LLC
- Product
- Jack Daniels Tennessee Whiskey Cake - Chocolate - Net Wt 8 O…
- Reason
- Cakes are potentially moldy prior to their "best by" date.
- Published
- November 6, 2019
- Distribution
- Distributed to retail stores in CA, NC,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Blue Bell Creameries, L.P.
- Product
- Blue Bell Butter Crunch Ice Cream packaged in a 1/2 Gallon (…
- Reason
- Possible foreign material in product.
- Published
- November 6, 2019
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
Terminated
Historical recordClass II
Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th Ave., Phoenix, AZ 85085. NDC 42852-006-20
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of sterility assurance.
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-984-10
by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Reason
- Lack of Assurance of Sterility; bags have potential to leak
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-988-10
by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Reason
- Lack of Assurance of Sterility; bags have potential to leak
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-526-20
by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Reason
- GMP Deviations: potential glass contamination
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (500 mcg/312.5 mg)/250 mL, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-530-25
by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Reason
- GMP Deviations: potential glass contamination
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL, Rx Only, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC 69374-0525-25
by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Reason
- GMP Deviations: potential glass contamination
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Lipari Foods Operating Company, LLC.
- Product
- Premo and Fresh Grab Ham & Cheese wheat sandwich, 5 oz., wit…
- Reason
- Products contain chicken which has been recalled by supplier because it may be contaminated with Listeria monocytogenes
- Published
- October 30, 2019
- Distribution
- The product was distributed to food serv…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Lipari Foods Operating Company, LLC.
- Product
- Premo Signature Cranberry Almond Chicken Salad croissant san…
- Reason
- Products contain chicken which has been recalled by supplier because it may be contaminated with Listeria monocytogenes
- Published
- October 30, 2019
- Distribution
- The product was distributed to food serv…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Lipari Foods Operating Company, LLC.
- Product
- Premo and Fresh Grab Chicken Salad wheat sandwiches, 5 oz.,…
- Reason
- Products contain chicken which has been recalled by supplier because it may be contaminated with Listeria monocytogenes
- Published
- October 30, 2019
- Distribution
- The product was distributed to food serv…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Mrs. Stratton's Salads, Inc
- Product
- Tuna salad under the following brand names: BALLARDS FARM Ba…
- Reason
- Potential contamination from Listeria monocytogenes.
- Published
- October 30, 2019
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Threshold Enterprises Ltd
- Product
- Source Naturals Dietary Supplement Brain Charge Advanced…
- Reason
- Labeling error; incorrect supplement facts panel and label claims for two ingredients were lower than the product formulation.
- Published
- October 30, 2019
- Distribution
- U.S. distribution to the following: AL,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Roland Foods, LLC
- Product
- Roland Brand Red Caviar - Whole Grain Lumpfish (Lumpfish Roe…
- Reason
- Potential to be contaminated with Clostridium botulinum.
- Published
- October 30, 2019
- Distribution
- Products were distributed in US states:…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Roland Foods, LLC
- Product
- Roland Brand Black Caviar - Whole Grain Lumpfish (Lumpfish R…
- Reason
- Potential to be contaminated with Clostridium botulinum.
- Published
- October 30, 2019
- Distribution
- Products were distributed in US states:…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Truck Farm, LLC
- Product
- Tia Rita's Spicy Southwestern Green Chile Cornbread dry mix.…
- Reason
- The product contains wheat flour, but does not declare wheat on the label.
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Orlando, FL 32839
by Ingenus Pharmaceuticals Llc
- Reason
- Crystallization: Presence of particulate matter identified as API crystallization
- Published
- October 23, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-284-90
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
- Published
- October 23, 2019
- Distribution
- Product was distributed to MS, OH, RI, T…
View recall →
FDA Recall
Terminated
Historical recordClass II
Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, Mixed Salts of a single Entity Amphetamine Product), 20mg, 100-count bottle, RX Only, Distributed by: Aurobindo Pharma USA Inc., Dayton, NJ 08810, NDC 13107-073-01
by Aurobindo Pharma USA Inc.
- Reason
- Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
- Published
- October 23, 2019
- 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.