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 →
FDA Recall
Terminated
Historical recordClass III
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534
by Zydus Pharmaceuticals USA Inc
- Reason
- Failed Dissolution Specifications; 6 month time point
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Simply Fresh Fruit
- Product
- 3 GL PAIL SFF SEASONAL FRUIT MIX B, UPC 4294710277
- Reason
- Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Simply Fresh Fruit
- Product
- 2/1 GL SFF TROPICAL MIX IN GRAPE JUICE, UPC 4294727161
- Reason
- Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Simply Fresh Fruit
- Product
- **1) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC #5075810 8449874…
- Reason
- Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Simply Fresh Fruit
- Product
- 1 GL CVF CANTALOUPE CHUNKS - LS, UPC 50758108449775;
- Reason
- Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Simply Fresh Fruit
- Product
- 1 GL CVF FRUIT SALAD DELUXE IN GRAPE JUICE, UPC 507581084557…
- Reason
- Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Simply Fresh Fruit
- Product
- 2 GL, 1 GL PAIL SFF CANT/CHUNKS GRAPE JUICE, UPC 4294717119
- Reason
- Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Simply Fresh Fruit
- Product
- 4/1 GL SYSCO FRUIT MIX GRAPE JUICE, UPC 10074865624296
- Reason
- Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Simply Fresh Fruit
- Product
- 2 GL PAIL SYSCO IMP. FRUIT MIX W/GRAPE JUICE, UPC 7486563430
- Reason
- Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Simply Fresh Fruit
- Product
- 1 GL PAIL SYSCO IMP. CANTALOUPE/GRAPE JUICE, UPC 7486562450
- Reason
- Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Simply Fresh Fruit
- Product
- 1 GL PAIL SYSCO FRUIT MIX - LS, UPC 7486540223; 4 GL Pail UP…
- Reason
- Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.
- 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.
Read the full medical disclaimer.