FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sunset Natural Products Inc.
- Product
- Oyster Dietary Supplement (unknown container size)
- Reason
- Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
- Published
- January 4, 2017
- Distribution
- Products distributed to Florida, Nevada…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sunset Natural Products Inc.
- Product
- Chromium Picolinate Dietary Supplement (unknown container si…
- Reason
- Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
- Published
- January 4, 2017
- Distribution
- Products distributed to Florida, Nevada…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sunset Natural Products Inc.
- Product
- Sugar Burner Dietary Supplement (unknown container size)
- Reason
- Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
- Published
- January 4, 2017
- Distribution
- Products distributed to Florida, Nevada…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sunset Natural Products Inc.
- Product
- DHEA 25 mg, bulk capsules
- Reason
- Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
- Published
- January 4, 2017
- Distribution
- Products distributed to Florida, Nevada…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sunset Natural Products Inc.
- Product
- Strev, bulk capsules
- Reason
- Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
- Published
- January 4, 2017
- Distribution
- Products distributed to Florida, Nevada…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sunset Natural Products Inc.
- Product
- Colon Therapy, bulk capsules
- Reason
- Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
- Published
- January 4, 2017
- Distribution
- Products distributed to Florida, Nevada…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sunset Natural Products Inc.
- Product
- Arganine & Pine Bark, bulk capsules
- Reason
- Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
- Published
- January 4, 2017
- Distribution
- Products distributed to Florida, Nevada…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sunset Natural Products Inc.
- Product
- Equs Mas, (30 capsules per bottle)
- Reason
- Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
- Published
- January 4, 2017
- Distribution
- Products distributed to Florida, Nevada…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sunset Natural Products Inc.
- Product
- Liver Energy, 100 capsules per bottle
- Reason
- Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
- Published
- January 4, 2017
- Distribution
- Products distributed to Florida, Nevada…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sunset Natural Products Inc.
- Product
- Test Booster, 90 or 60 capsules per bottle
- Reason
- Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
- Published
- January 4, 2017
- Distribution
- Products distributed to Florida, Nevada…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sunset Natural Products Inc.
- Product
- Project #3, 60 capsules per bottle
- Reason
- Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
- Published
- January 4, 2017
- Distribution
- Products distributed to Florida, Nevada…
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 →
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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