FDA Drugs recall ·
Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units… recall
- Recall number
- D-0633-2026
- Date
- (initiated June 2, 2026)
- Company / brand
- Dabur India Limited
225 - 4 - 1 Saily Village, Dadra And Nagar Haveli, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 84 tubes
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 3.5 mg, Polymyxin-B Sulfate 5,000 units, net wt. 2oz (57g) tubes, Distributed by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 10096 77162 9.
Why was it recalled?
CGMP Deviations; deficiencies observed during FDA inspection
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot# 0004, within expiry
Distribution
US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0633-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.