Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
babyganics
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What 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.
Drug: Zinc
- Recalling firm
- Johnson, S C and Son, Inc
- Origin
- WI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0298-2025 · 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.
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Class II · Moderate risk
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CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
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Class II · Moderate risk
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Class II · Moderate risk
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