Severity
Moderate
ModerateClass IIOngoing
FDA Drug recall · Reported April 2, 2025
babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada.
Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Johnson, S C and Son, Inc recalled babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7… - a moderate-severity action.
babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7… was recalled by Johnson, S C and Son, Inc in April 2, 2025. Reason: Failed stability specifications: during routine stability monitoring quality concerns were identified. Physic…. Check the official notice for the remedy. Verify recall #D-0298-2025 with the FDA Drug before acting.
The recall
Johnson, S C and Son, Inc issued this moderate-severity FDA Drug recall-Failed stability specifications: during routine stability monitoring quality concerns were identified. Physic….
- Moderate
- severity level
- Class II
- classification
- April 2, 2025
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0298-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0298-2025) was formally reported on April 2, 2025, with the manufacturer initiating the action on January 8, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Johnson, S C and Son, Inc is listed as the recalling firm, operating out of Racine, WI. Federal records list the affected scope as 57,184 bottles.
The documented reason for this recall is: Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed. Distribution data in the federal record shows the product reached: Nationwide in the USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
57,184 bottles
Related Recalls
6
0 from same agency
Product description
babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada.
Reason for recall
Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0298-2025 |
| Date reported | April 2, 2025 |
| Date initiated | January 8, 2025 |
| Recalling firm | Johnson, S C and Son, Inc |
| Firm location | Racine, WI |
| Affected scope | 57,184 bottles |
| Distribution | Nationwide in the USA |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0298-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada.. Recalled by Johnson, S C and Son, Inc. Units affected: 57,184 bottles.
Why was this product recalled? ▼
Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 2, 2025. Severity: Moderate. Recall number: D-0298-2025.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0298-2025) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported April 2, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.