Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Jun 26, 2024 (2 years ago)

Blemfree All Day Lotion (Salicylic Acide)

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.

Cause type: cGMP deviation

Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.

What was recalled

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

Affected NDCs 53228-0002-01 53228-0003-01

Compare with the code on your package — it is the most precise check available.

Product details

From the FDA NDC directory, for the product codes this recall names. Compare with the label on your package.

ProductStrengthForm & routeLabelerType
BlemFree
Salicylic Acid
NDC 53228-0002		 .587 g/118mL Lotion
Topical		 Equibal, Inc. OTC
Blemfree
Salicylic Acide
NDC 53228-0003		 SALICYLIC ACID 1500 mg/29000mg Lotion
Topical		 Equibal, Inc. OTC
Recalling firm
Equibal Inc
NDC code
53228-002-01
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0591-2024 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other cgmp deviation recalls from 2024

All cgmp deviation recalls
Class II · Moderate risk

Henry Schein

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

Terminated cGMP deviation Keystone Industries D-0148-2025