FDA Recall
Terminated
Historical recordClass III
DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-0212-50
by Fresenius Medical Care Holdings, Inc.
- Reason
- Temperature Abuse: Product exposed to temperature outside specified limits.
- Published
- June 16, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL (NDC 49230-209-30) and c) 5000 mL (NDC 49230-209-50) Rx only, Fresenius Medical Care NA Waltham, MA 02451
by Fresenius Medical Care Holdings, Inc.
- Reason
- Temperature Abuse: Product exposed to temperature outside specified limits.
- Published
- June 16, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50
by Fresenius Medical Care Holdings, Inc.
- Reason
- Temperature Abuse: Product exposed to temperature outside specified limits.
- Published
- June 16, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10
by Fresenius Medical Care Holdings, Inc.
- Reason
- Temperature Abuse: Product exposed to temperature outside specified limits.
- Published
- June 16, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Sun Hong Foods, Inc.
- Product
- Seafood Mushroom Keep Refrigerated Net Wt. 5.3 oz./150g D…
- Reason
- Potential L. mono contamination due to CDPH product sample findings.
- Published
- June 16, 2021
- Distribution
- U.S. distribution to the following: CA,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Arizona Nutritional Supplements
- Product
- 365 Everyday Value Whey Protein Powder Natural Vanilla Flavo…
- Reason
- Whey Protein Powder was mistakenly packaged with Soy Protein Powder.
- Published
- June 16, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
The Kroger Co
- Product
- Chicken Street Taco kit in a plastic tray with a clear plast…
- Reason
- Undeclared egg allergen for Chipotle Crema on product label.
- Published
- June 16, 2021
- Distribution
- Distributed to UT, NM, NV, AZ, WY, MT, I…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Hy-Vee Stores Inc
- Product
- Hy-Vee Chicken Street taco kit, Net Wt. 18 OZ, UPC 282503 2…
- Reason
- Product contains chipotle crema as part of a taco kit which contains undeclared major food allergen egg
- Published
- June 16, 2021
- Distribution
- Distributed to Hy-Vee grocery stores in…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Coca-Cola Company
- Product
- Glaceau Vitaminwater XXX labeled to be Glaceau Vitaminwater…
- Reason
- Product labeled to be "zero sugar" may contain sugar due to an incorrect label being used.
- Published
- June 16, 2021
- Distribution
- Distributed to distributors in AL, AR, C…
View recall →
FDA Recall
Terminated
Historical recordClass I
1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial (NDC 0409-4279-16), packaged in 25 vials per tray (NDC 0409-4279-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.
by PFIZER, INC
- Reason
- Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
- Published
- June 9, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 0409-1162-19), packaged in 25 vials per tray (NDC 0409-1162-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.
by PFIZER, INC
- Reason
- Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
- Published
- June 9, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manufactured By: Oxford Pharmaceuticals, LLC Birmingham, Alabama 35211, NDC 69584-093-10
by Oxford Pharmaceuticals, LLC
- Reason
- Presence of Foreign Tablets/Capsules
- Published
- June 9, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per carton, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA; Manufactured by: Mylan Institutional, Galway, Ireland. NDC: 67457-196-02
by Mylan Institutional LLC
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.
- Published
- June 9, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Reser's Fine Foods, Inc.
- Product
- ***Chicken Street Taco Kit with Trays, item # 13454.38080, R…
- Reason
- Undeclared egg. The cup of Chipotle Crema in the Chicken Street Taco kits contains undeclared egg.
- Published
- June 9, 2021
- Distribution
- distributed in AL, CO, FL, GA, IA, IL, I…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Genpak
- Product
- Bake n Show¿ Oven Ready Food Tray 16 ounce
- Reason
- The firm was notified via a customer complaint that they found foreign objects in the packaging of the product.
- Published
- June 9, 2021
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Genpak
- Product
- Bake n Show¿ Cake Tray Round & Bake n Show¿ Cake Tray Squa…
- Reason
- The firm was notified via a customer complaint that they found foreign objects in the packaging of the product.
- Published
- June 9, 2021
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Genpak
- Product
- Bake n Show¿ Pizza Cookie Tray 12"
- Reason
- The firm was notified via a customer complaint that they found foreign objects in the packaging of the product.
- Published
- June 9, 2021
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Genpak
- Product
- Bake n Show¿ Muffin Tray 4 Cavity Large, Bake n Show¿ Muff…
- Reason
- The firm was notified via a customer complaint that they found foreign objects in the packaging of the product.
- Published
- June 9, 2021
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Genpak
- Product
- Bake n Show¿ Angel Food Tray 8 Inch & 8 inch shallow
- Reason
- The firm was notified via a customer complaint that they found foreign objects in the packaging of the product.
- Published
- June 9, 2021
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Hi Tech Pharmaceuticals
- Product
- Lipodrene With 25mg Ephedra Extract 100CT UPC 8 57084 00056…
- Reason
- The firm was notified by the FDA that the product contains the unapproved food additive 1,4-dimethylamylamine (DMAA).
- Published
- June 9, 2021
- Distribution
- The product was shipped to the following…
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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