Lidocaine HCl Injection USP Recall Issued
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Asclemed USA Inc. is recalling specific lots of Lidocaine HCl Injection USP, 1% due to lack of assurance of sterility.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 6, 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
Asclemed USA Inc. initiated a voluntary recall due to lack of assurance of sterility for the affected product.
Which Products Are Affected
Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, NDC 85766-187-01, distributed by Enovachem Pharmaceuticals, Torrance, CA. Affected lots: AE3102, 031926L01, 032026A01 (Exp 11/30/2026); AE5052, 052026G01 (Exp 04/30/2028). Recall number D-0659-2026. Distributed USA Nationwide.
What You Should Do
Consumers and healthcare providers should not use the affected product and should contact their healthcare provider or the recalling firm for further instructions.
Why This Matters
This ongoing Class II recall involves a human prescription drug distributed nationwide.
Source
FDA recall D-0659-2026
Original source: FDA Official Notice ↗
Related FDA Recalls
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.
Similar body length
Nearest notices by article body length (804 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 6, 2026.
Frequently Asked Questions
Common questions about this FDA recall.