Dietary supplement recalled because it contains magnesium salicylate
Professional Botanicals is recalling 430 bottles of Total Comfort capsules because the product contains magnesium salicylate.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: an undisclosed pharmacologically active salicylate in a supplement can reach people who must avoid it, and no illnesses are reported.
Plain-English summary
Total Comfort, in 175cc HDPE bottles of 60 vegetable capsules with a two-capsule dose, product SKU PB173, from Professional Botanicals, is being recalled because the product contains magnesium salicylate.
The recall covers 430 bottles from lot 280914. The product was distributed nationwide, including Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota and Missouri. The FDA has classified the recall as Class II.
Salicylates are avoided by people with a salicylate sensitivity and by others on medical advice, so an undisclosed salicylate in a supplement matters. The enforcement record reports no illnesses.
Anyone holding a bottle from lot 280914 should stop taking it and contact the firm or their prescriber.
The recalled product
- Product
- Product Name: Total Comfort. Package: 175cc HDPE Bottle. Type: Vegetable Capsule Count: 60, Dose: 2 Capsules. Product Sku: PB173.
- Manufacturer
- Professional Botanicals, Inc.
- Category
- Food — Dietary supplement
- Affected units
- 430
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: 280914
Distribution
Part of a larger recall action
This product is one of 3 recalled by Professional Botanicals, Inc. under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Professional Botanicals, Inc.
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