FDA recall, , Moderate risk
Direct Rx Lidocaine Ointment
Lidocaine Ointment USP, 5.0 % 50g JAR may be weaker than labeled.
Summary by Recall Canary from the FDA notice
What happened
Direct Rx of Dawsonville, Georgia, voluntarily recalled Lidocaine Ointment USP, 5.0 % 50g JAR, Rx only, because the product is subpotent. The recall began on September 29, 2026, and was added to the FDA's Enforcement Report on October 29, 2026. The product was distributed nationwide within the United States.
The ointment was packaged and distributed by Direct Rx, Dawsonville, GA 30534. Customers were notified by letter. The recall was classified by the FDA on October 29, 2026, and in the FDA's weekly enforcement report on November 4, 2026.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your jar affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Lidocaine Ointment USP, 5.0 % 50g JAR
- NDC
- 72189-0211-50
- Lot code
- 03AP2511
- 30AP2518
- 18JU2519
- 18JU2520
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Oct 26, 2026
- Sold in
Nationwide within the United States
- Recalled by
- Direct RxDawsonville, Georgia
- Hazard
- Wrong drug strength
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 100229
- Recall number
- D-0107-2027
- Quantity recalled
- 493 jars
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Direct Rx began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
Summary updated
