Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Circle K
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations; deficiencies observed during FDA inspection
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
Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g) tubes, Product manufactured for Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC 1 94283 65181 0.
Drug: Zinc
- Recalling firm
- Dabur India Limited
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0631-2026 · 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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