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Trifluent recalls Tridacaine III lidocaine patch

The FDA recall list names Trifluent Pharma's Tridacaine III Lidocaine Patch 5%, but the listing excerpt gives almost no detail on why.

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Primary document: FDA recall: Trifluent Pharma LLC — Tridacaine III / Lidocaine Patch 5%, 15 envelopes containing 1 patch each per po

The FDA's recalls, market withdrawals and safety alerts page lists a recall of Tridacaine III / Lidocaine Patch 5% from Trifluent Pharma LLC. The product description reads 15 envelopes, each containing one patch, per pouch. That is the whole of what the excerpt tells you about the product.

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The FDA page lists the Trifluent product with a product description of 15 envelopes, one patch each, per pouch, and no recall reason in the excerpt.

The page is a running table. The version I read was current as of 11/09/2026, and the Trifluent entry is not in the set of rows visible in that excerpt. The other rows are a vancomycin vial with glass particulate (Eugia US LLC, dated 11/09/2026), a sandwich with possible Listeria, a kale chip with thallium, a toddler bar with a choking hazard, and several food and supplement recalls. The Trifluent line sits in the same table format, so I am treating it as a listed recall. I could not open the Trifluent notice itself from the material provided.

What the listing says

The entry gives a brand name, a product description and a company name. It does not give a recall date, a reason, a lot number, a distribution range or a recall class in the text I was given. The reason field is the one that matters most to an owner, and the source leaves it blank.

Lidocaine patches are a product category many practices stock for procedure prep and for patients who ask about numbing before a treatment. If you buy Tridacaine III or any Trifluent patch, the page does not tell you whether your lot is affected.

What it means for practices (our read)

The thin excerpt is the story. A recall with no stated reason can mean a labeling problem, a packaging or sterility issue, or a potency question. Each of those leads to a different action at the chair. We would not guess which one applies.

Owners should not assume the recall is minor because the page is short. Recalls on the FDA list range from a choking hazard to a contaminated injectable on the same page, and the list does not rank them for you.

What owners can do

Check your stock today. Pull any Trifluent or Tridacaine III boxes on the shelf and note the lot numbers and expiration dates printed on the carton and the envelopes.

Open the Trifluent recall notice from the FDA page before you use another patch from that stock. The company name and brand are the search terms to use on the FDA site.

Call Trifluent Pharma directly if the notice does not list your lot. Ask whether your lot is in scope, what the reason is, and what they want done with product already on hand.

Quarantine any affected units in a labeled bin, not in the treatment room. Document the count and the date. Keep the record with your purchasing file.

If a patient received a patch from a lot in question and reports a reaction, record it and follow your adverse-event process. Report the event to the FDA through MedWatch.

Pull the lidocaine patch from your procedure kit until you have checked the lot. Replacing one patch costs far less than explaining one.

What we don't know yet

The excerpt does not give the recall reason, the lot or lots affected, the date the recall began, the distribution area, or whether Trifluent has a full notice posted. It also does not say whether the recall is ongoing or has been terminated. We will update this piece when the full Trifluent notice is available to us.

Business information, not medical or legal advice. Verify regulatory status at FDA.gov.

Source: original report ↗

Business information, not medical or legal advice. Verify product status at FDA.gov.

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