Rapidol Triple Antibiotic Ointment Recall

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Dabur India Limited is recalling 84 tubes of Rapidol Triple Antibiotic First Aid Ointment due to CGMP deviations observed during FDA inspection.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on August 1, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.

What Happened

Dabur India Limited initiated a voluntary recall of Rapidol Triple Antibiotic First Aid Ointment due to CGMP deviations, with deficiencies observed during an FDA inspection. The recall is classified as Class II and remains ongoing.

Which Products Are Affected

The affected product is 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. A total of 84 tubes are involved, distributed US Nationwide. The product is from Lot# 0004, within expiry. Recall number D-0633-2026. Recalling firm address: 225 - 4 - 1 Saily Village, Survey No, Dadra And Nagar Haveli, India.

What You Should Do

Consumers should verify the lot number on purchased tubes against Lot# 0004.

Why This Matters

The recall affects a limited quantity of ointment distributed nationwide due to manufacturing practice deviations.

Source

FDA recall D-0633-2026

Original source: FDA Official Notice ↗

All FDA Recalls →

Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Dabur India Limited is recalling 84 tubes of Rapidol Triple Antibiotic First Aid Ointment due to CGMP deviations observed during FDA inspection.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.