Direct Rx Recalls Subpotent Lidocaine Ointment Jars Nationwide
Direct Rx is recalling 493 jars of Lidocaine Ointment USP 5.0% because the product is subpotent. The recall covers lots distributed nationwide in the United States.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II due to the product being subpotent, which may cause temporary or medically reversible adverse health consequences. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Direct Rx is voluntarily recalling 493 jars of Lidocaine Ointment USP, 5.0% 50g JAR, prescription only. The recall was initiated on September 29, 2026, and is currently ongoing. The product is identified by NDC 72189-0211-50 and is packaged and distributed by Direct Rx in Dawsonville, Georgia.
The reason for the recall is that the drug is subpotent, meaning it contains less of the active ingredient than labeled. The affected lots are 03AP2511, 30AP2518, 18JU2519, and 18JU2520, all with an expiration date of 04/30/2027. The FDA has classified this recall as Class II.
The product was distributed nationwide within the United States. The source text does not report any illnesses, injuries, or deaths associated with this recall. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled description.
The recalled product
- Product
- Lidocaine Ointment USP, 5.0 % 50g JAR, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534, NDC 72189-0211-50
- Manufacturer
- Direct Rx
- Category
- Drug — Topical Anesthetic
- Hazard
- Affected units
- 493
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 (5)
- LOT#: 03AP2511
- 30AP2518
- 18JU2519
- 18JU2520
- Exp. Date 04/30/2027.
Distribution
Distributed nationwide across the United States.
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