CLASS II ONGOING Drug recall · Reported 2 Apr 2025 · FDA Enforcement Report
babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance recalled
Johnson, S C and Son is recalling babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a), distributed nationwide in the US. The recall was initiated on 8 Jan 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0298-2025
- FDA event ID
- 96334
- Recalling firm
- Johnson, S C and Son, Racine, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Jan 2025
- FDA classified
- 25 Mar 2025
- Reported
- 2 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Sunscreen & Personal Care
Timeline
| 8 Jan 2025 | Recall initiated by company | |
| 25 Mar 2025 | Classified by FDA | +76 days |
| 2 Apr 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Is babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) recalled?
Yes. Johnson, S C and Son recalled babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) on 8 Jan 2025. The recall is Class II and its status is Ongoing. Recall number D-0298-2025.
Why was it recalled?
Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Which lots are affected?
Lot #: a) 097C4/C080316, Exp 03/31/2026; b) 177K3/A303407, Exp 10/31/2025
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Johnson, S C and Son
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Kids by babyganics SPF 50 totally tropical recalled | Johnson, S C and Son | Packaging Defects | Nationwide |
| Drug | CLASS II | Kids by babyganics SPF 50 mineral sunscreen totally recalled | Johnson, S C and Son | Packaging Defects | Nationwide |