Blemfree All Day Lotion (salicylic acid 0.5% w/w) recall
FDA recall D-0591-2024 · initiated Jun 26, 2024
Equibal Inc recalled Blemfree All Day Lotion (salicylic acid 0.5% w/w) in Jun 2024 — an FDA Class II recall (D-0591-2024) because CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 90/1 oz. tubes and 248/4 oz. bottles
Details
- 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
- Recalling company
- Equibal Inc
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA via internet sales.
- Initiated
- Jun 26, 2024
- FDA report date
- Jul 17, 2024
Frequently asked
- Was Blemfree All Day Lotion (salicylic acid 0.5% w/w) recalled?
- Equibal Inc recalled Blemfree All Day Lotion (salicylic acid 0.5% w/w) in Jun 2024 — an FDA Class II recall (D-0591-2024) because CGMP Deviations: Manufactured without following Current Good Manufacturing Practises. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Blemfree All Day Lotion (salicylic acid 0.5% w/w) recalled?
- Per the FDA enforcement record, the reason for recall D-0591-2024 was: CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
- Is a recalled Blemfree All Day Lotion (salicylic acid 0.5% w/w) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Blemfree All Day Lotion (salicylic acid 0.5% w/w) are affected?
- Distributed: Nationwide in the USA via internet sales.. The recall covers these lots — Lot # a) BF063221, exp. date 03/04/2025, BF097221, exp. date 04/07/2025, b) BF097221 exp date 04/07/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0591-2024.