FDA Recall
Ongoing
Historical recordClass II
GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and c) 800 mL (NDC 61924-106-27), and d) 1000 mL (NDC 61924-106-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
by DermaRite Industries, LLC
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
by DermaRite Industries, LLC
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-214-04
by DermaRite Industries, LLC
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) per bag (NDC 61924-092-27), and c 1000 mL (34 fl. oz.) per bag (NDC 61924-092-34), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
by DermaRite Industries, LLC
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), and b)106 g (3.75 oz.) per tube (NDC 61924-234-04) DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
by DermaRite Industries, LLC
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%), packaged in a) 106 g (3.75 oz.) per tube (NDC 61924-174-04) and b) 454 g (16 oz.) per jar (NDC 61924-174-16), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
by DermaRite Industries, LLC
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-208-04
by DermaRite Industries, LLC
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals, Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274. Packaged by GSMS, Incorporated, Carmarillo, CA 93012. NDC: 51407-268-90
by Golden State Medical Supply Inc.
- Reason
- Failed Dissolution Specifications
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bottle, Rx only, Mfg by: Imprimis NJOF, LLC, 1705 Route 46 West, Ledgewood, NJ 07852, NDC 71384-514-05
by Imprimis NJOF, LLC
- Reason
- Subpotent Drug
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30
by Alembic Pharmaceuticals Limited
- Reason
- Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
BULK & ORGANIC LLC
- Product
- Bulk and Organic Organic Moringa Powder, 44.1lbs bag
- Reason
- Possible Salmonella Richmond
- Published
- November 26, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Lotus Vaping Technologies, LLC
- Product
- Monarch Premium Kratom White Elephant powder is packaged in…
- Reason
- Product has the potential to be contaminated with Salmonella
- Published
- November 19, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Lotus Vaping Technologies, LLC
- Product
- Monarch Premium Kratom Red Bali powder is packaged in seal m…
- Reason
- Product has the potential to be contaminated with Salmonella
- Published
- November 19, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Lotus Vaping Technologies, LLC
- Product
- Monarch Premium Kratom Green Maeng Da powder is packaged in…
- Reason
- Product has the potential to be contaminated with Salmonella
- Published
- November 19, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Lotus Vaping Technologies, LLC
- Product
- Monarch Premium Kratom Bali Gold powder is packaged in seal…
- Reason
- Product has the potential to be contaminated with Salmonella
- Published
- November 19, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Professional Botanicals, Inc.
- Product
- Product Name: Tense-X. Package: 175cc HDPE Bottle. Type: Veg…
- Reason
- Products contains Magnesium Salicylate.
- Published
- November 19, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Professional Botanicals, Inc.
- Product
- Product Name: Total Comfort. Package: 175cc HDPE Bottle. Typ…
- Reason
- Products contains Magnesium Salicylate.
- Published
- November 19, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Professional Botanicals, Inc.
- Product
- Product Name: Nutra Calm Package: 175cc HDPE Bottle. Type: V…
- Reason
- Products contains Magnesium Salicylate.
- Published
- November 19, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
FreshRealm
- Product
- Loaded Veggie Grain Bowl; Net Wt. 10.90 Oz (309g) GTIN code:…
- Reason
- Potential contamination with Listeria monocytogenes
- Published
- November 19, 2025
- Distribution
- Product was manufactured and shipped dir…
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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