FDA Recall
Terminated
Historical recordClass III
Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 62756-129-40
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Impurity/Degradation Specifications
- Published
- February 17, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India NDC 16729-472-08 (Vial NDC 16729-472-30)
by ACCORD HEALTHCARE, INC.
- Reason
- Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
- Published
- February 17, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Bickel's Snack Foods Inc
- Product
- Butter Flavored Popcorn Artificially Flavored 8oz. UPC:70173…
- Reason
- Undeclared milk due to mislabeling
- Published
- February 17, 2021
- Distribution
- The product was sold to distributors in…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
EVR FOODS INC
- Product
- "LAVVA Blueberry Dairy Free Pili Nut Yogurt. NO SUGAR ADDED.…
- Reason
- Product may contain mold.
- Published
- February 17, 2021
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Glanbia Performance Nutrition (Manufacturing), Inc
- Product
- think! Protein + Fiber Oatmeal, Farmer's Market Berry Crumbl…
- Reason
- Undeclared ingredients including but not limited to pecans and almonds
- Published
- February 17, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
World Finer Foods, Inc.
- Product
- Reese Hollandaise Sauce packaged in glass jars 7.5 oz UPC: 7…
- Reason
- Reports of compromised vacuum seal and product expansion which may lead to growth of microorganisms
- Published
- February 17, 2021
- Distribution
- Distributed to distribution centers in C…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
World Finer Foods, Inc.
- Product
- Reese Bearnaise Sauce packaged in glass jars 7.5 oz UPC: 706…
- Reason
- Reports of compromised vacuum seal and product expansion which may lead to growth of microorganisms
- Published
- February 17, 2021
- Distribution
- Distributed to distribution centers in C…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Maine Grains, Inc
- Product
- Maine Grains Inc. brand Organic Yellow Peas sold between 10/…
- Reason
- Product contains undeclared soy.
- Published
- February 17, 2021
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. NDC: 29033-056-01
by Nostrum Laboratories Inc
- Reason
- CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
- Published
- February 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Made in India NDC 55150-307-01
by AuroMedics Pharma LLC
- Reason
- Discoloration and failed pH specifications
- Published
- February 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad, Maharashtra, India. NDC: 68180-678-01
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
- Published
- February 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 NDC 51672-4001-1
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- CGMP deviations.
- Published
- February 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Goodman Food Products Texas Inc
- Product
- O Organics Plant Based Mushroom and Veggie Organic Burger Pa…
- Reason
- Labeling error caused product to claim Gluten Free and Vegan when it contains wheat and dairy
- Published
- February 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Wildtree Inc.
- Product
- "Wildtree***Taco Seasoning***Organic & Gluten Free***Net Wt.…
- Reason
- Spice mixes contain undeclared gluten due to contaminated ingredient.
- Published
- February 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Wildtree Inc.
- Product
- "Wildtree***Leslies Chili Blend***Organic & Gluten Free***Ne…
- Reason
- Spice mixes contain undeclared gluten due to contaminated ingredient.
- Published
- February 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Door County Coffee & Tea Co., Inc.
- Product
- Door County Coffee & Tea Co. French Vanilla Flavored Cappucc…
- Reason
- Retail Box did not contain list of ingredients or allergen statement.
- Published
- February 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Dole Fresh Vegetables Inc
- Product
- Dole Endless Summer Salad Kit; 13 oz. bag UPC: 0-71430-010…
- Reason
- Two consumer complaints received for incorrect Master pack in Endless Summer salad kit - undeclared fish and eggs in Caesar dressing that was inadvertently included.
- Published
- February 10, 2021
- Distribution
- US distribution only- AZ, CA, CO, IA, ID…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Champlain Chocolate Company
- Product
- Lake Champlain chocolates -Classic Chocolate Bar Library 1.1…
- Reason
- Chocolate may contain plastic pieces
- Published
- February 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Champlain Chocolate Company
- Product
- Lake Champlain chocolates - Milk Chocolate Bar Library 1.1…
- Reason
- Chocolate may contain plastic pieces
- Published
- February 10, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Champlain Chocolate Company
- Product
- Lake Champlain chocolates -FIVE STAR ALMOND Dark Chocolate…
- Reason
- Chocolate may contain plastic pieces
- Published
- February 10, 2021
- 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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