FDA Recall
Ongoing
Historical recordClass I
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
by Supercore Products Group Inc.
- Reason
- Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
- Published
- October 9, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 gm Tube, NDC 68462-0455-47; c) 100 gm Tube, NDC 68462-0455-94, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Defective Container: Firm received complaints of broken tube at the seal.
- Published
- October 9, 2024
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India, NDC: 75834-257-01.
by Nivagen Pharmaceuticals Inc
- Reason
- Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
- Published
- October 9, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mac & Co
- Product
- Mini Raspberry Lemon Coffee Cake, net wt. 13.5oz. UPC 8 572…
- Reason
- Undeclared walnut and wheat. Mini Squash Harvest Loaf (UPC 8 55324 00505 3) was mis-labeled as Mini Raspberry Lemon Coffee Cake (UPC 8 57297 00745 4) and therefore wheat flour and walnuts are not declared on label.
- Published
- October 9, 2024
- Distribution
- Distributed in WA only
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FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Grace Imports, Inc
- Product
- KARA BOONDHI INGREDIENTS: Gram flour, Edible beg oil (Refine…
- Reason
- Undeclared wheat. The firm was notified by their supplier that they failed to include the allergen "wheat" on the label.
- Published
- October 9, 2024
- Distribution
- Product were shipped to retail stores in…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Blue Tape Sriracha
- Product
- Blue Tape Sriracha sauce is refrigerated condiment, packaged…
- Reason
- Acidified product was manufactured by firm without ODA license.
- Published
- October 9, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Grace Imports, Inc
- Product
- SPICY MURUKKU INGREDIENTS: Rice Flour, Edible Veg Oil (Refin…
- Reason
- Undeclared wheat. The firm was notified by their supplier that they failed to include the allergen "wheat" on the label.
- Published
- October 9, 2024
- Distribution
- Product were shipped to retail stores in…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Grace Imports, Inc
- Product
- KERALA MIXTURE INGREDIENTS: Gram Flour 48%, Edible Veg Oil (…
- Reason
- Undeclared wheat. The firm was notified by their supplier that they failed to include the allergen "wheat" on the label.
- Published
- October 9, 2024
- Distribution
- Product were shipped to retail stores in…
View recall →
FDA Recall
Ongoing
Historical recordClass II
Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-427-12.
by Ascend Laboratories, LLC
- Reason
- Failed Dissolution Specifications
- Published
- October 2, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1
by EnviroServe Chemicals Inc.
- Reason
- CGMP deviations
- Published
- October 2, 2024
- Distribution
- Product was sent to one distributor in N…
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FDA Recall
Ongoing
Historical recordClass II
Infla-650 Herbal Dietary Supplement, 700mg, packaged in pouches containing 60 capsules, Distributed by: Guru Inc., 4370 Lawrenceville Hwy NW, P.O. Box 2204, Lilburn, GA 30047-1100, USA. Ph.: 872 216 1566, http://www.dalayurevda.com, Made in India, UPC: 042535355019
by Guru Inc.
- Reason
- Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
- Published
- October 2, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230312042
by AbbVie Inc.
- Reason
- Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
- Published
- October 2, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043,
by AbbVie Inc.
- Reason
- Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
- Published
- October 2, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041 NDC 72627-2424-1.
by Empower Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- October 2, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Vivier Sheer SPF 30 Mineral With Antioxidants (titanium dioxide 10% and zinc oxide 8%) packaged in 60 ml/2 fl oz, Vivier Canada Inc. / Mfd. for Vivier Pharma, Vaudereull-Dorion OC Canada, J7V 5V5, Champlain, NY USA 12919, Made in Canada, NDC 67226-2232-6. SKU 10-160-ZZ-80059-R
by Vivier Pharma, Inc.
- Reason
- Microbial Contamination of Non-Sterile Product
- Published
- October 2, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06
by Mckesson Medical-Surgical Inc. Corporate Office
- Reason
- Temperature abuse: Products exposed to improper temperature above drug label specifications.
- Published
- October 2, 2024
- Distribution
- Product was distributed to two medical f…
View recall →
FDA Recall
Completed
Historical recordClass II
Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, 07430, NDC 68462-180-22.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Subpotent Drug
- Published
- October 2, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Niitakaya USA Inc
- Product
- Miso Katsuo Ninniku (Pickled Garlic), Net WT 5.2 OZ (147g) P…
- Reason
- Undeclared allergen (Fish) Ingredient
- Published
- October 2, 2024
- Distribution
- Affected products were distributed in 7…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Niitakaya USA Inc
- Product
- Shiso Katsuo Ninniku (Pink Pickled Garlic), Net WT 5.2 OZ (1…
- Reason
- Undeclared allergen (Fish) Ingredient
- Published
- October 2, 2024
- Distribution
- Affected products were distributed in 7…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Skagit River Bakery & Cafe
- Product
- Blueberry Scones, bulk packaged in cake boxes with parchment…
- Reason
- Undeclared soy lecithin and soybean oil on label
- Published
- October 2, 2024
- Distribution
- Distributed in WA.
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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