FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
CSM Bakery Products NA
- Product
- ZT Carrot Bread Mix, 13.5#
- Reason
- Undeclared allergen; Peanut Protein
- Published
- November 30, 2016
- Distribution
- AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
CSM Bakery Products NA
- Product
- Buffets Corn Muffin Mix, 30# Bag
- Reason
- Undeclared allergen; Peanut Protein
- Published
- November 30, 2016
- Distribution
- AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
CSM Bakery Products NA
- Product
- Logans Rdhse Yeast Roll Mix, 21.5#
- Reason
- Undeclared allergen; Peanut Protein
- Published
- November 30, 2016
- Distribution
- AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
CSM Bakery Products NA
- Product
- BM Westco Sup-R-Roll Donut Mix, 50#
- Reason
- Undeclared allergen; Peanut Protein
- Published
- November 30, 2016
- Distribution
- AR, CA, CO, DE, FL, GA, IL, MN, NJ, NC,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Westby Coop Creamery
- Product
- 4% cottage cheese packaged in 16-ounce, 22-ounce, and 24-oun…
- Reason
- The firm is conducting a recall of the 4% cottage cheese because the product tested positive for residue phosphatase.
- Published
- November 30, 2016
- Distribution
- WI and IL
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Infiniti Creations, LLC
- Product
- Slim Life. 2oz HCG Drops. Blue Plastic
- Reason
- The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.
- Published
- November 30, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Infiniti Creations, LLC
- Product
- Slimming Herbs. 2oz HCG Drops. Amber Glass
- Reason
- The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.
- Published
- November 30, 2016
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Infiniti Creations, LLC
- Product
- Official HCG Diet Plan. 1oz, 2oz & 4oz HCG Drops. Amber Plas…
- Reason
- The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.
- Published
- November 30, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Infiniti Creations, LLC
- Product
- Supervision Weightloss. 2oz HCG Drops. Amber Glass
- Reason
- The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.
- Published
- November 30, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Infiniti Creations, LLC
- Product
- HCG Plus. 2oz HCG Drops. Blue Glass
- Reason
- The firm announced a voluntary recall of various dietary supplement products due to misbranding and some products may contain undeclared HCG.
- Published
- November 30, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g), Manufactured for: Steifel Laboratories, Inc., Research Triangle Park, NC 27709, UPC 0 73462 15065 1; NDC 0145-1506-01
by GSK Consumer Healthcare
- Reason
- Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the incorrect indication stating "use for the cure of most jock itch" rather than "use for the cure of most athlete's foot".
- Published
- November 23, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 66758-005-02), Rx only, Manufactured for: Sandoz, Inc., Princeton, NJ.
by Sandoz Inc
- Reason
- Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
- Published
- November 23, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per carton (NDC 66758-004-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
by Sandoz Inc
- Reason
- Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
- Published
- November 23, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03
by CutisPharma, Inc.
- Reason
- Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
- Published
- November 23, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05
by CutisPharma, Inc.
- Reason
- Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
- Published
- November 23, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories
by Amerisource Health Services
- Reason
- Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
- Published
- November 23, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Conifer Specialties, Inc.
- Product
- Simply Balanced brand White Chicken Chili dry soup mix. Thi…
- Reason
- Simply Balanced brand White Chili dry soup mix is recalled because it was contaminated with metal shavings.
- Published
- November 23, 2016
- Distribution
- distributed in CA, IN, MI, NC, NY, OH, O…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
McCain Foods USA
- Product
- Frozen Onion Rings sold and distributed under the following…
- Reason
- Product label does not declare milk.
- Published
- November 23, 2016
- Distribution
- Recalled product was distributed to dire…
View recall →
FDA Recall
Terminated
Historical recordClass III
Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, NDC 51079-882-20
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
- Published
- November 16, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.
- Published
- November 16, 2016
- 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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