First Aid Beauty conducted a voluntary recall of 2,756 jars of its Ultra Repair Cream – Coconut Vanilla Scent (14 oz) on December 14, 2024, because of a batch meant to be in quarantine for internal review. The recall occurred following our internal quality control audits that indicated an internal breakdown in quarantine standards were in place for use by the company. Even though there are no reported adverse events to date, we must act promptly due to the unauthorized release of the product, which could compromise the entire batch and thus the product's safety or efficacy. [1]

First Aid Beauty’s Ultra Repair Cream Recall (December 2024)

Recall , May 22, 2025

First Aid Beauty conducted a voluntary recall of 2,756 jars of its Ultra Repair Cream – Coconut Vanilla Scent (14 oz) on December 14, 2024, because of a batch meant to be in quarantine for internal review. The recall occurred following our internal quality control audits that indicated an internal breakdown in quarantine standards were in place for use by the company. Even though there are no reported adverse events to date, we must act promptly due to the unauthorized release of the product, which could compromise the entire batch and thus the product’s safety or efficacy. [1]

Reason Behind the Recall

This recall was enacted preventatively for consumer safety and to protect manufacturing integrity. If a product is to be held “quarantined,” the product was likely held because pending test results or concerns regarding formulation, packaging, or microbial stability. If the containment of the units could not be assured, then distribution of these unit’s phasor the manufacturer’s internal controls and could present an unknown risk to users in accordance with FDA’s Good Manufacturing Practices (GMPs), these lapses require quick remedial action to avert potential health effects. [2]

Root Cause Analysis

The initial findings disclosed that the impacted lots (24D44 and 24D45) had been mistakenly released from the hold in the clearance process due to some form of miscommunication. First Aid Beauty’s investigation identified a systems level defect with their inventory tagging and release process, where a quality control identifier was not updated properly. While there were no contamination or formulation issues identified, the batch constitutes a GMP violation since it did not satisfy the full release criteria and was circulated in the market prior to full release. The manufacturer acted voluntarily to protect the consumer and showed their strictness on a zero tolerance for deviating from protocol. [3]

Product Description

Brand: First Aid Beauty
Product Name: Ultra Repair Cream – Coconut Vanilla Scent
Packed Size: 14 oz pail
Lot codes: 24D44, 24D45
Expiration date: April 2026
Issue: Unintentional release of a product that was intended for quarantine
Recall Classification: Class II Risk (May cause temporary or reversible adverse health consequences)

Issue Identified

The product in question, while stable in terms of product quality, was not cleared to be sold to market because final QC paperwork was not complete before the distribution occurred. Since the release involved lots under quarantine status, there was concern about whether microbial safety, stability, or allergen profile could be assured. This is what led to a Class II recall classification based on FDA guidelines stating that use of the product would result in temporary health consequences for some people – especially those with sensitive skin or may have compromised immunity. [4]

Regulatory Body Concerns

The FDA states that all quarantined products should be physically and functionally separate from all other products until documentation of their full release has been granted.
The inadvertent release of quarantined products is a violation of 21 CFR Par211 on finished product release and labeling.
Non-conformance with GMP invokes an immediate product stop, remedial training, and an in-depth internal audit on posting and labeling.
Regulatory authorities have emphasized the need for a stronger quality assurance/warehouse interaction and SOPs to follow from the neighbor sectors of COSMETIC and COSMECEUTICAL. [5]

Manufacturer’s Consumer Guidance

The First Aid Beauty brand has issued a public recall notice on its main website and major retailers across the country for the consumers. Here is advice for consumers:

Stop using the impacted product right away.
Throw away any product with the lot number 24D44 or 24D45.
Reach out the customer service for a replacement or full refund of the product.
If they have had any skin irritation or reactions related to the affected product, consumers should report it to their healthcare provider or the FDA’s MedWatch program.

First Aid Beauty is confirming that there are no other lot numbers or product types affected by this recall. The company will institute better quarantine management and new methods to validate product releases to ensure it does not happen again. [6]

FRL Commentary

This recall has underscored the critical importance of robust quarantine release systems and inter-department collaboration in cosmeceutical manufacturing activities. FRL highly recommends that organisations:

Integrate electronic batch tracking with automated quarantine status notifications.
Conduct pre-release stability and microbial testing with Certificate of Analysis (CoA) on a single batch.
Validate distribution clearances with a barcode scan during the warehouse stage.

Stay Informed About Regulatory Recalls

FRL assists companies in the cosmeceutical and nutraceutical arena with GMP audits, product recall readiness plans, and SOP creation for risk mitigation from mislabeling, contaminants, or procedural mistakes.

Concluding Remarks: The Basics of GMP in Cosmeceuticals

In non-ingestible products, quarantined batches can still return with reputational and regulatory consequences. This example demonstrates that product safety with cosmeceuticals requires strict GMP compliance, cross-departmental accountability and procedures, and real-time inventory control procedures. Getting compliance with the FDA in addition to government regulations for cosmetics around the world is crucial for avoiding recalls and maintaining consumer confidence in their functional skincare products.