FDA Recall
Terminated
Historical recordClass II
infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-23, UPC 0 78742 02016 7.
by Tris Pharma Inc.
- Reason
- Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
- Published
- December 26, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection, 100 mL total volume in a 150 mL Intravia Bag, Rx Only,PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732. NDC 61553-148-48
by PharMEDium Services, LLC
- Reason
- Sub-potent
- Published
- December 26, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732 NDC 61553-644-75.
by PharMEDium Services, LLC
- Reason
- Sub-potent
- Published
- December 26, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-089-01
by Epic Pharma, LLC
- Reason
- Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
- Published
- December 26, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Bakkavor Foods USA Inc.
- Product
- Baked Macaroni and Cheese, NET WT 12 OZ (340g), CONTAINS: WH…
- Reason
- Product contains Lobster, Shrimp, and Soy which are not included on the label.
- Published
- December 26, 2018
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
ASK Foods Inc
- Product
- ASK Foods Inc. Naturally Creative Firecracker Slaw, 3.75 lb.…
- Reason
- Products recalled due to potential contamination with Listeria monocytogenes or Salmonella.
- Published
- December 26, 2018
- Distribution
- Product Distributed in the following Sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
ASK Foods Inc
- Product
- ASK Foods Inc. Naturally Creative, Roasted Corn and Edamame…
- Reason
- Products recalled due to potential contamination with Listeria monocytogenes or Salmonella.
- Published
- December 26, 2018
- Distribution
- Product Distributed in the following Sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
ASK Foods Inc
- Product
- ASK Foods Inc. Rigatoni Casserole, 5 lb. Aluminum Tray Pan s…
- Reason
- Products recalled due to potential contamination with Listeria monocytogenes or Salmonella.
- Published
- December 26, 2018
- Distribution
- Product Distributed in the following Sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
ASK Foods Inc
- Product
- ASK Foods Inc. Smokey Mozzarella Pasta Salad, 4 lb. Bulk Co…
- Reason
- Products recalled due to potential contamination with Listeria monocytogenes or Salmonella.
- Published
- December 26, 2018
- Distribution
- Product Distributed in the following Sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
ASK Foods Inc
- Product
- Taste of Inspirations Rotini Salad, Net Wt. 13 oz., Pre-pack…
- Reason
- Products recalled due to potential contamination with Listeria monocytogenes or Salmonella.
- Published
- December 26, 2018
- Distribution
- Product Distributed in the following Sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
ASK Foods Inc
- Product
- Wegmans Roasted Corn and Bean Salad; 13 oz. Plastic Contain…
- Reason
- Products recalled due to potential contamination with Listeria monocytogenes or Salmonella.
- Published
- December 26, 2018
- Distribution
- Product Distributed in the following Sta…
View recall →
FDA Recall
Ongoing
Historical recordClass II
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC 0093-7809-56) & 90-count bottles (NDC 0093-7809-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
by Teva Pharmaceuticals USA
- Reason
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Published
- December 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
by Teva Pharmaceuticals USA
- Reason
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Published
- December 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7810-56) & 90-count bottles (NDC 0093-7810-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
by Teva Pharmaceuticals USA
- Reason
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Published
- December 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) & 90-count bottles (NDC 0093-7807-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
by Teva Pharmaceuticals USA
- Reason
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Published
- December 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) & 90-count bottles (NDC 0093-7693-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
by Teva Pharmaceuticals USA
- Reason
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Published
- December 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-7692-56) & 90-count bottles (NDC 0093-7692-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
by Teva Pharmaceuticals USA
- Reason
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Published
- December 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) & 90-count bottles (NDC 0093-7691-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
by Teva Pharmaceuticals USA
- Reason
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Published
- December 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
by Teva Pharmaceuticals USA
- Reason
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Published
- December 19, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-121-01; b) 90 count bottle NDC 69367-121-03
by Westminster Pharmaceuticals LLC
- Reason
- CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
- Published
- December 19, 2018
- 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.