B-Lipo Capsules Recalled for Containing Unapproved Controlled Substance Lorcaserin
Bethel Nutritional Consulting is recalling B-Lipo capsules because they contain Lorcaserin, a controlled substance, and were marketed without FDA approval.
The agency’s classification
FDA (Drugs): 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric. The presence of an unapproved controlled substance in a dietary supplement represents a significant regulatory and safety hazard.
Plain-English summary
Bethel Nutritional Consulting, Inc. is recalling B-Lipo, 30 Capsules, manufactured by KM DALI in Kunming, China. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The FDA determined that the capsules contain Lorcaserin, a controlled substance used for weight loss. The recall affects Lot #20213, which has an expiration date of 12/22/2016. The product was distributed nationwide.
Consumers who have purchased this product should stop using it and contact Bethel Nutritional Consulting, Inc. for further instructions or a refund.
The recalled product
- Product
- B-Lipo, 30 Capsules, Manufactured by KM DALI, Kunming, China for Bethel Nutritional Consulting, Inc.599 West 190th Street, Suite #1 NYC, NY 10040.
- Manufacturer
- Bethel Nutritional Consulting, Inc
- Category
- Drug — Dietary Supplement
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 (2)
- Lot #: 20213
- Exp 12/22/2016.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Bethel Nutritional Consulting, Inc
See all →- CriticalSLIM-K Capsules Recalled for Unapproved Dangerous Ingredients
FDA (Drugs) · 2015-07-15
- SevereBethel Advance capsules recalled for unapproved drug ingredients
FDA (Drugs) · 2013-12-25
- CriticalQuick Thin capsules recalled for containing unapproved drugs
FDA (Drugs) · 2013-12-25
- CriticalBethel 30 capsules recalled for undeclared active ingredients
FDA (Drugs) · 2013-09-04
Same hazard · unapproved ingredient
See all →- Severe
- HighAlpha Test supplement capsules recalled for unapproved cathine ingredient
FDA (Food) · 2025-02-05
- HighTruvy Boost Dietary Supplement Kit Recalled for Unapproved Ingredients
FDA (Food) · 2023-05-31
- ModerateDietary supplement Tight! Xtreme Reloaded recalled for unapproved ingredient
FDA (Food) · 2021-06-30
- SevereFDA Recalls PremierZen Black 5000 for Unapproved Tadalafil
FDA (Drugs) · 2021-05-26
Similar recalls
- CriticalSLIM-K Capsules Recalled for Unapproved Dangerous Ingredients
FDA (Drugs) · 2015-07-15
- CriticalLidiy capsules recalled for undeclared sibutramine and lack of FDA approval
FDA (Drugs) · 2014-04-23
- CriticalBethel 30 capsules recalled for undeclared active ingredients
FDA (Drugs) · 2013-09-04
- SevereFUCONPO Capsule Recalled for Marketing Without Approved NDA or ANDA
FDA (Drugs) · 2016-07-20
- CriticalDr. Ming's Chinese Capsule Recalled for Undeclared Sibutramine and Phenolphthalein
FDA (Drugs) · 2014-04-16
- CriticalB-50 Capsules Recalled for Containing Unapproved Steroid Ingredients
FDA (Drugs) · 2014-03-12