FDA Recall
Terminated
Historical recordClass III
Techni-Care Surgical Hand Scrub and Patient Preoperative Skin Preparation (3.0% w/v Chloroxylenol), packaged in a) 4 oz. bottles (NDC 46706-201-01), b) 8 oz bottles (NDC 46706-201-02), c) 16 oz. bottles (NDC 46706-201-03), d) 12 oz. pumpette (NDC 46706-201-05), e) 32 oz. bottles (NDC 46706-201-06), OTC, Care-Tech Laboratories, Inc., St. Louis, MO 63139
by Care-Tech Laboratories, Inc.
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date - Product is missing or has illegible lot and expiry codes, as well as defective or cracked caps.
- Published
- January 4, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Western United Fish Company, Inc.
- Product
- Limu Poke is fresh refrigerated product, distributed in bulk…
- Reason
- Limu Poke (seaweed tuna) is recalled due to a potential for contamination with Salmonella. This product contains affected seaweed (Kahuku Ogo) which was recalled by Marine Agrifuture, LLC.
- Published
- January 4, 2017
- Distribution
- Alaska, Arizona, California, Colorado, I…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Bio-Botanica, Inc.
- Product
- Liquid VITAMIN D-3 Drops distributed under the following pri…
- Reason
- The lots exceed the label claim for Vitamin D3 of 2000 IU per drop.
- Published
- January 4, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Cargill Cocoa & Chocolate, Inc.
- Product
- Wilbur; IM10021; B558 Semisweet Chocolate Drops, 2000 CT; Ne…
- Reason
- Cargill Cocoa & Chocolate is recalling 50 lb. cartons of Wilbur B558 Semi-Sweet Chocolate Drops because it may contain undeclared milk.
- Published
- January 4, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80; c) 3-count disposable barrier cloths per package, 50 packages per carton, 2 cartons (100 packages) per case, Reorder # 7502, NDC 53462-915-51; d) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7508, NDC 53462-915-81; e) 24-count disposable barrier cloths per tub, 12 packages per case, Reorder # 7524, NDC 53462-915-60; f) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013.
by Sage Products LLC
- Reason
- CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
by Making It a Lifestyle
- Reason
- Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02
by Hospira Inc., A Pfizer Company
- Reason
- Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-308-10.
by VIRTUS PHARMACEUTICALS OPCO II L
- Reason
- Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10.
by VIRTUS PHARMACEUTICALS OPCO II L
- Reason
- Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705, b) Reorder #9701-P, and c) Reorder #9780, Sage Products LLC 3909 Three Oaks Road, Cary, Illinois 60013, NDC 53462-705-20.
by Sage Products LLC
- Reason
- CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80; c) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013.
by Sage Products LLC
- Reason
- Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick, Distributed by: Tom's of Maine, Kennebunk, ME 04043, Made in Canada, Unit UPC: 077326831953 Case UPC: 10077326831950
by Les Emballages Knowlton Inc.
- Reason
- Labeling: Label Mix Up- Incorrect back label applied to the product.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle
by Love My Tru Body
- Reason
- Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
3rd DEGREE capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
by Making It a Lifestyle
- Reason
- Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
by Making It a Lifestyle
- Reason
- Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only, Rx Only, Manufactured by: Novo Nordisk A/S 2880 Bagsvaerd, Denmark, NDC 0169-7065-15
by Novo Nordisk Inc
- Reason
- Defective delivery system: detached needles on the syringe in the kit.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection, Inc. (a Honeywell Company), Platteville, WI 53818
by Sperian Eye & Face Protection, Inc
- Reason
- Non Sterility; contaminated with Klebsiella pneumoniae
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA
by Impax Laboratories, Inc.
- Reason
- Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10.
by VIRTUS PHARMACEUTICALS OPCO II L
- Reason
- Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007.
by Ultimate Body Tox
- Reason
- Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
- Published
- December 28, 2016
- 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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