FDA Recall
Ongoing
Historical recordClass III
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
- Published
- December 10, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass III
Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.
by Teva Pharmaceuticals USA, Inc
- Reason
- Defective Container - A defect in the side-seal which allows leakage of product.
- Published
- December 10, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ 07059. Vial NDC# 69097-708-31; Carton NDC 69097-708-96
by Cipla Limited
- Reason
- Failed Stability Specifications: Observed OOS results: eg results for colour index
- Published
- December 10, 2025
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Great Lakes Cheese Co Inc
- Product
- Food Club Finely Shredded Pizza Style Four Cheese Blend (con…
- Reason
- Potential metal fragments from supplier raw material (downstream recall)
- Published
- December 10, 2025
- Distribution
- AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN,…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass I
Genepro Protein, Inc.
- Product
- Genepro Whey 4th Generation Plasma Treated Protein, unflavor…
- Reason
- Product is mislabeled - the labeling contains incorrect ingredient information and fails to declare milk as an allergen
- Published
- December 10, 2025
- Distribution
- Multiple states
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ventura Foods Llc
- Product
- Publix Deli Carolina-Style Mustard BBQ Sauce; 96- 2OZ NET WT…
- Reason
- foreign objects (black plastic planting material) in granulated onion
- Published
- December 10, 2025
- Distribution
- The firm distributed product to 7 retail…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ventura Foods Llc
- Product
- Italian Salad Dressing; Net 1 GAL (3.78L) SKU: 7 67367 0051…
- Reason
- foreign objects (black plastic planting material) in granulated onion
- Published
- December 10, 2025
- Distribution
- The firm distributed product to 7 retail…
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FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass III
Avion Pharmaceuticals, LLC
- Product
- Prenate Chewable¿ A chewable Rx prenatal vitamin with a deli…
- Reason
- Undeclared Soy. The firm received positive test results for soy which is not listed on the label. The firm also noticed that the amount of boron in the product is listed as 250mg per serving instead of 250mcg per serving.
- Published
- December 10, 2025
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Prime Food Processing LLC.
- Product
- Lava Bun with Salted Egg Yolk orange packaging (Frozen) U…
- Reason
- Products do not declare milk in the Contains statement or the ingredient statement.
- Published
- December 10, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Prime Food Processing LLC.
- Product
- Lava Bun with Green Tea Flavor bright lime green packaging…
- Reason
- Products do not declare milk in the Contains statement or the ingredient statement.
- Published
- December 10, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Blonde Beard's
- Product
- Blonde Beard's Dojo Asian Wing Sauce, wing sauce hot sauce c…
- Reason
- Undeclared Soy
- Published
- December 10, 2025
- Distribution
- Product was distributed to Canada and th…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Great Lakes Cheese Co Inc
- Product
- Good & Gather Mozzarella & Parmesan shredded cheese blend, F…
- Reason
- Potential metal fragments from supplier raw material (downstream recall)
- Published
- December 10, 2025
- Distribution
- AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Great Lakes Cheese Co Inc
- Product
- Mozzarella and provolone shredded cheese blend (containing l…
- Reason
- Potential metal fragments from supplier raw material (downstream recall)
- Published
- December 10, 2025
- Distribution
- AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Great Lakes Cheese Co Inc
- Product
- Pizza style shredded cheese blend (containing low-moisture p…
- Reason
- Potential metal fragments from supplier raw material (downstream recall)
- Published
- December 10, 2025
- Distribution
- AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Great Lakes Cheese Co Inc
- Product
- Italian style shredded cheese blend (containing low-moisture…
- Reason
- Potential metal fragments from supplier raw material (downstream recall)
- Published
- December 10, 2025
- Distribution
- AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Great Lakes Cheese Co Inc
- Product
- Happy Farms by Aldi Italian Style shredded cheese blend (con…
- Reason
- Potential metal fragments from supplier raw material (downstream recall)
- Published
- December 10, 2025
- Distribution
- AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Great Lakes Cheese Co Inc
- Product
- Low-moisture part-skim mozzarella shredded cheese, individua…
- Reason
- Potential metal fragments from supplier raw material (downstream recall)
- Published
- December 10, 2025
- Distribution
- AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Water Pure, Inc.
- Product
- My Bladder; Supports normal bladder tone & control; Dietary…
- Reason
- Product may be contaminated with E. coli O7:K1 (IAI39/ExPEC) and E. coli 1303
- Published
- December 10, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, CA 92211. NDC: 35192-052-18, UPC 8 18204 02513 8
by CA BOTANA International, Inc.
- Reason
- CGMP Deviations
- Published
- December 3, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 35192-046-17
by CA BOTANA International, Inc.
- Reason
- CGMP Deviations
- Published
- December 3, 2025
- 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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