Direct Rx Lidocaine Ointment Recall: Subpotent Drug Risk
Direct Rx recalls 493 jars of Lidocaine Ointment USP 5.0% due to subpotent drug issues. Check lot numbers and expiration dates for affected units.
Use caution until it’s fixed
Subpotent Drug
What happened, in plain English
Direct Rx is recalling Lidocaine Ointment USP, 5.0%, packaged in 50g jars because the product may be subpotent. This means the medication might not contain the full amount of active ingredient needed to work as intended. The recall affects approximately 493 jars distributed nationwide. Read more at govinfonow.com/recall/2084835-direct-rx-recalls-lidocaine-ointment-usp-5-0-50g-jar.
Source Summary by GovInfoNow · govinfonow.com/recall/2084835-direct-rx-recalls-lidocaine-ointment-usp-5-0-50g-jar · Published November 10, 2026 · Updated November 11, 2026 · FDA enforcement record: FDA #D-0107-2027
Cite this page
“Direct Rx Lidocaine Ointment Recall: Subpotent Drug Risk.” GovInfoNow, updated November 11, 2026. https://govinfonow.com/recall/2084835-direct-rx-recalls-lidocaine-ointment-usp-5-0-50g-jar. Based on FDA recall #D-0107-2027 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0107-2027%22&limit=1).
Why it’s dangerous
The primary hazard is that the drug is subpotent, meaning it contains less of the active ingredient than labeled. This can lead to inadequate pain management or failure to treat the condition for which it was prescribed.
Who’s affected
Individuals who have purchased and are using Lidocaine Ointment USP, 5.0% from Direct Rx, particularly those relying on it for pain relief. The risk is that the treatment may be ineffective due to lower-than-stated potency.
How to tell if you have this one
Check your jar for the brand Direct Rx and the label 'Lidocaine Ointment USP, 5.0% 50g JAR'. Affected items have NDC 72189-0211-50 and lot numbers: 03AP2511, 30AP2518, 18JU2519, or 18JU2520. The expiration date is 04/30/2027.
- Brand
Direct Rx- Category
Drug
What to do — step by step
Check Your Product
Verify if your jar matches the NDC 72189-0211-50 and one of the specified lot numbers (03AP2511, 30AP2518, 18JU2519, 18JU2520).
Contact Direct Rx
Since the remedy is not stated in the record, contact Direct Rx directly for instructions on what to do with the product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 36 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0107-2027 (September 29, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0107-2027 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on November 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.