The Recall Desk
SevereFDA (Drugs)·D-0770-2021·Announced 2021-09-01

Miss Slim capsules recalled for unapproved marketing distribution

HIS ENTERPRISE INC is recalling all lots of Miss Slim capsules (10-count and 30-count boxes) distributed nationwide in the USA because the product was marketed without required FDA approval (ANDA/NDA).

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall of a drug product marketed without required regulatory approval (ANDA/NDA). Class II recalls are classified as Severe per the rubric, as they indicate significant regulatory violations involving unapproved drugs that may pose unknown safety risks.

Plain-English summary

HIS ENTERPRISE INC is recalling all lots of Miss Slim capsules, packaged in both 10-count and 30-count boxes (UPC 742137605030), distributed nationwide throughout the USA. The product is being recalled because it was marketed without the required FDA approval through either an Abbreviated New Drug Application (ANDA) or New Drug Application (NDA).

Consumers who have purchased Miss Slim capsules should stop using the product. Those with questions or concerns should contact HIS ENTERPRISE INC or consult their healthcare provider.

The recalled product

Product
Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030
Manufacturer
HIS ENTERPRISE INC
Category
Drug — Dietary supplement / Weight management
Hazard
  • unapproved-drug
  • lack-of-approval

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)

  • all lots

Distribution

Distributed nationwide across the United States.

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