FDA Recall
🇺🇸 United States
TerminatedTerminated: March 1, 2017Historical recordClass I
Houdini Inc.
- Product
- Vintners Path Chardonnay Seasons Greetings Basket #795
- Reason
- Potential Salmonella contamination.
- Published
- February 8, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 15, 2017Historical recordClass III
Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-0293-99
by Roxane Laboratories, Inc.
- Reason
- Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
- Published
- February 1, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 11, 2018Historical recordClass III
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-0738-86
by Sun Pharmaceutical Industries, Inc.
- Reason
- Failed Dissolution Specifications; 18 month stability time point
- Published
- February 1, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 11, 2018Historical recordClass III
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88) and c) 500 (NDC 47335-737-13) count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India
by Sun Pharmaceutical Industries, Inc.
- Reason
- Failed Dissolution Specifications; 18 month stability time point
- Published
- February 1, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: January 25, 2018Historical recordClass II
Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98.
by Mylan LLC.
- Reason
- Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
- Published
- February 1, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: January 25, 2018Historical recordClass II
Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b) 14-count bottles (NDC 0378-5264-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
by Mylan LLC.
- Reason
- Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
- Published
- February 1, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: January 25, 2018Historical recordClass II
Temozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-98), b) 14-count bottles (NDC 0378-5263-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
by Mylan LLC.
- Reason
- Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
- Published
- February 1, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: January 25, 2018Historical recordClass II
Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
by Mylan LLC.
- Reason
- Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
- Published
- February 1, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 5, 2018Historical recordClass III
Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92880 USA, Mfd. by Cipla Ltd. Verna, Goa India, NDC 0591-3467-53
by Actavis Inc
- Reason
- Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
- Published
- February 1, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 17, 2017Historical recordClass III
DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56
by Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
- Reason
- Failed Impurities/ Degradation Specifications
- Published
- February 1, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 18, 2017Historical recordClass II
Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-4297-31.
by Roxane Laboratories, Inc.
- Reason
- Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
- Published
- February 1, 2017
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: May 26, 2017Historical recordClass II
Harris Teeter
- Product
- Everroast Chicken Caesar Wrap, UPC: 72036-95828, in clear fl…
- Reason
- Undeclared allergen (fish)
- Published
- February 1, 2017
- Distribution
- DC, DE, FL, GA, MD, NC, SC, VA.
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FDA Recall
🇺🇸 United States
TerminatedTerminated: December 28, 2017Historical recordClass I
Boulder Brands, LLC
- Product
- Earth Balance Vegan Cheddar flavored Mac and Cheese, 6oz pac…
- Reason
- Earth Balance Vegan White Cheddar flavored Mac and Cheese and Earth Balance Vegan Cheddar flavored Mac and Cheese with undeclared allergen, milk.
- Published
- February 1, 2017
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: December 28, 2017Historical recordClass I
Boulder Brands, LLC
- Product
- Earth Balance Vegan White Cheddar flavored Mac and Cheese, 6…
- Reason
- Earth Balance Vegan White Cheddar flavored Mac and Cheese and Earth Balance Vegan Cheddar flavored Mac and Cheese with undeclared allergen, milk.
- Published
- February 1, 2017
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: April 13, 2017Historical recordClass II
Schreiber Food International
- Product
- Ambrosia Quality Foods Brand 4/1 gallon Worcestershire Sauce…
- Reason
- Ambrosia brand 4/1 Gallon Worcestershire Sauce may contain undeclared peanuts.
- Published
- February 1, 2017
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: April 13, 2017Historical recordClass II
Authentic Alaska
- Product
- Alaska Salmon Bites (jerky), Rhubarb & Raspberries flavor, D…
- Reason
- Alaska Salmon Bites (jerky), Rhubarb & Raspberries flavor is recalled due to undeclared soy. Product contains undeclared soy sauce from the ingredient Tamari sauce.
- Published
- February 1, 2017
- Distribution
- distributed in CA and MD.
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FDA Recall
🇺🇸 United States
TerminatedTerminated: April 13, 2017Historical recordClass II
Authentic Alaska
- Product
- Alaska Salmon Bites (jerky), Spicy Fireweed Honey flavor, De…
- Reason
- Alaska Salmon Bites (jerky), Spicy Fireweed Honey flavor is recalled due to undeclared soy. Product contains undeclared soy sauce from the ingredient Tamari sauce.
- Published
- February 1, 2017
- Distribution
- distributed in CA and MD.
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FDA Recall
🇺🇸 United States
TerminatedTerminated: July 12, 2019Historical recordClass II
Dutch-American Foods Inc
- Product
- Blueberry Donut , ST8300-50, NET WT. 50 LBS
- Reason
- Dutch-American foods is recalling various seasoning products and baking bases due to potential contamination of product with Salmonella.
- Published
- February 1, 2017
- Distribution
- Multiple states
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FDA Recall
🇺🇸 United States
TerminatedTerminated: July 12, 2019Historical recordClass II
Dutch-American Foods Inc
- Product
- Danish Base, ST1250B-50, NET WT. 50 LBS
- Reason
- Dutch-American foods is recalling various seasoning products and baking bases due to potential contamination of product with Salmonella.
- Published
- February 1, 2017
- Distribution
- Multiple states
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FDA Recall
🇺🇸 United States
TerminatedTerminated: July 12, 2019Historical recordClass II
Dutch-American Foods Inc
- Product
- Gourmet Cocoa Supreme, CP302141-12, NET WT. 12 LBS
- Reason
- Dutch-American foods is recalling various seasoning products and baking bases due to potential contamination of product with Salmonella.
- Published
- February 1, 2017
- Distribution
- Multiple states
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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