Rapidol Topical Antibiotic Ointment Recalled for Manufacturing Deviations
Rapidol triple antibiotic ointment (lot SP27A, expiring 09/30/2026) distributed in Delaware and North Carolina was recalled for manufacturing practice deviations. The voluntary recall was initiated April 24, 2025, and terminated February 19, 2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for manufacturing practice deviations in a topical antibiotic product. While no illnesses have been reported, CGMP deviations represent a risk-of-harm scenario in pharmaceutical manufacturing.
Plain-English summary
Rapidol triple antibiotic ointment, manufactured by Kenil Healthcare Private Limited and distributed by Pharmadel LLC, was recalled due to manufacturing practice deviations.
The affected product was Rapidol triple antibiotic ointment (containing bacitracin zinc, neomycin sulfate, and polymyxin B sulfate), supplied in 2-ounce tubes. The recall applied to lot SP27A, with an expiration date of September 30, 2026. Approximately 9,336 tubes were distributed in Delaware and North Carolina.
The manufacturer voluntarily initiated the recall on April 24, 2025, after manufacturing practice deviations were identified. The FDA classified this as a Class II recall. The recall was terminated on February 19, 2026.
The recalled product
- Product
- RAPIDOL (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE)
- Brand
- RAPIDOL
- Manufacturer
- KENIL HEALTHCARE PRIVATE LIMITED
- Category
- Drug — Topical Antibiotic
- Hazard
- manufacturing-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot SP27A
- Exp: 09/30/2026
UPCs (1)
- 810096771629
Distribution
Distributed in 2 states:
- DE
- NC
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