FDA Recall
Terminated
Historical recordClass III
Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.
by Akorn, Inc.
- Reason
- Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
- Published
- April 4, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1
by Amneal Pharmaceuticals
- Reason
- Presence of particulate matter
- Published
- April 4, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427. NDC: 0574-2067-27
by Paddock Laboratories, LLC.
- Reason
- Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.
- Published
- April 4, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-302-01.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.
- Published
- April 4, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10
by Renaissance Lakewood, LLC
- Reason
- Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
- Published
- April 4, 2018
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Piggie Park Enterprises Inc
- Product
- Maurice's Honey Southern Gold BBQ Sauce; Net Wt. 18 oz. bott…
- Reason
- Undeclared soy and wheat ingredients
- Published
- April 4, 2018
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
GRIFFITH FOODS
- Product
- Product Name Lot Number or ID Au Jus Seasoning Reduced…
- Reason
- Griffith Foods, Inc. has initiated a voluntary recall of multiple products following a supplier's recall of Autolyzed Yeast Powder due to the presence of Salmonella.
- Published
- April 4, 2018
- Distribution
- Domestic: IL, TX, VA, WI, OK, MS Fore…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
GRIFFITH FOODS
- Product
- Product Name Lot Number or ID Salt & Vinegar Seasoning…
- Reason
- Griffith Foods, Inc. has initiated a voluntary recall of multiple products following a supplier's recall of Autolyzed Yeast Powder due to the presence of Salmonella.
- Published
- April 4, 2018
- Distribution
- Domestic: IL, TX, VA, WI, OK, MS Fore…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
GRIFFITH FOODS
- Product
- Product Name Lot Number or ID Premix Roasted Chicken 12…
- Reason
- Griffith Foods, Inc. has initiated a voluntary recall of multiple products following a supplier's recall of Autolyzed Yeast Powder due to the presence of Salmonella.
- Published
- April 4, 2018
- Distribution
- Domestic: IL, TX, VA, WI, OK, MS Fore…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
GRIFFITH FOODS
- Product
- Product Name Lot Number or ID Roasted Wing Marinade Seaso…
- Reason
- Griffith Foods, Inc. has initiated a voluntary recall of multiple products following a supplier's recall of Autolyzed Yeast Powder due to the presence of Salmonella.
- Published
- April 4, 2018
- Distribution
- Domestic: IL, TX, VA, WI, OK, MS Fore…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
GRIFFITH FOODS
- Product
- Product Name Lot Number or ID Fire Roasted Steak Type S…
- Reason
- Griffith Foods, Inc. has initiated a voluntary recall of multiple products following a supplier's recall of Autolyzed Yeast Powder due to the presence of Salmonella.
- Published
- April 4, 2018
- Distribution
- Domestic: IL, TX, VA, WI, OK, MS Fore…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
GRIFFITH FOODS
- Product
- Product Name Lot Number or ID Toasted Italian Herbs 66112…
- Reason
- Griffith Foods, Inc. has initiated a voluntary recall of multiple products following a supplier's recall of Autolyzed Yeast Powder due to the presence of Salmonella.
- Published
- April 4, 2018
- Distribution
- Domestic: IL, TX, VA, WI, OK, MS Fore…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
GRIFFITH FOODS
- Product
- Product Name Lot Number or ID Pan Roast Brown Gravy Mix 6…
- Reason
- Griffith Foods, Inc. has initiated a voluntary recall of multiple products following a supplier's recall of Autolyzed Yeast Powder due to the presence of Salmonella.
- Published
- April 4, 2018
- Distribution
- Domestic: IL, TX, VA, WI, OK, MS Fore…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
GRIFFITH FOODS
- Product
- Product Name Lot Number or ID Whiskey & Cola Type Flavore…
- Reason
- Griffith Foods, Inc. has initiated a voluntary recall of multiple products following a supplier's recall of Autolyzed Yeast Powder due to the presence of Salmonella.
- Published
- April 4, 2018
- Distribution
- Domestic: IL, TX, VA, WI, OK, MS Fore…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Newly Weds Foods Inc
- Product
- Bourbon Brown Sugar Rub SE746665, 50# Bags
- Reason
- Newly Weds Foods, Inc. initiated a voluntary recall of dry blended seasonings for industrial use due to a supplier's recall of yeast because of the presence of salmonella.
- Published
- April 4, 2018
- Distribution
- Domestic: PA, IL, AR, KS Foreign: Non…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Newly Weds Foods Inc
- Product
- Roast Grill Seasoning SE746664, 50# Bags
- Reason
- Newly Weds Foods, Inc. initiated a voluntary recall of dry blended seasonings for industrial use due to a supplier's recall of yeast because of the presence of salmonella.
- Published
- April 4, 2018
- Distribution
- Domestic: PA, IL, AR, KS Foreign: Non…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Newly Weds Foods Inc
- Product
- Roast Chicken Marinade SE746125 and SE746126, 50# Bags
- Reason
- Newly Weds Foods, Inc. initiated a voluntary recall of dry blended seasonings for industrial use due to a supplier's recall of yeast because of the presence of salmonella.
- Published
- April 4, 2018
- Distribution
- Domestic: PA, IL, AR, KS Foreign: Non…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Newly Weds Foods Inc
- Product
- Lbs, flv roast dark type, 30 # Boxes
- Reason
- Newly Weds Foods, Inc. initiated a voluntary recall of dry blended seasonings for industrial use due to a supplier's recall of yeast because of the presence of salmonella.
- Published
- April 4, 2018
- Distribution
- Domestic: PA, IL, AR, KS Foreign: Non…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Newly Weds Foods Inc
- Product
- Au Jus Seasoning BM652767; bulk 50 lb boxes
- Reason
- Newly Weds Foods, Inc. initiated a voluntary recall of dry blended seasonings for industrial use due to a supplier's recall of yeast because of the presence of salmonella.
- Published
- April 4, 2018
- Distribution
- Domestic: PA, IL, AR, KS Foreign: Non…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mondelez Global Llc
- Product
- Sour Patch Kids, 1.9 lb bag
- Reason
- Mondelez Global LLC is initiating a recall because remnants of a half peanut shell were found in two containers of bulk candy from a single lot during the repacking process and the candy is not labeled as containing peanuts. Mondelez Global LLC after an investigation, including inspection of product within in their control from the same lot did not find any other evidence of peanut contamination. The firm believes this is most likely to be an isolated incident and that product on the market is unlikely to contain any peanut pieces and the product is not likely to cause adverse health consequences to peanut allergic consumers. No adverse health events have been reported. Never the less, out of an abundance of caution, we have determined to conduct a voluntary recall to the retail level.
- Published
- April 4, 2018
- Distribution
- The product has been distributed to the…
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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