Recalls / Class II
Class IID-0591-2024
Product
Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in a) 1 oz. 29 ML tube NDC:53228-003-01 b) 4 OZ 118ML plastic bottle, UPC 7 01450 90008 6, NDC # 53228-002-01, Equibal Labs, Inc
- Brand name
- Blemfree
- Generic names
- Salicylic Acide, Salicylic Acid
- Active ingredient
- Salicylic Acid
- Route
- Topical
- NDCs
- 53228-003, 53228-002
- FDA application
- M006
- Affected lot / code info
- Lot # a) BF063221, exp. date 03/04/2025, BF097221, exp. date 04/07/2025, b) BF097221 exp date 04/07/2025
Why it was recalled
CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
Recalling firm
- Firm
- Equibal Inc
- Manufacturer
- Equibal, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 63-65 Jersey Ave, N/A, Unionville, New York 10988
Distribution
- Quantity
- 90/1 oz. tubes and 248/4 oz. bottles
- Distribution pattern
- Nationwide in the USA via internet sales.
Timeline
- Recall initiated
- 2024-06-26
- FDA classified
- 2024-07-09
- Posted by FDA
- 2024-07-17
- Terminated
- 2026-04-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0591-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.