Lidocaine Hydrochloride Injection Recall Issued
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Spectra Medical Devices, LLC is recalling Lidocaine HCl Injection USP due to lack of assurance of sterility, affecting 210625 ampules distributed nationwide.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 9, 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Spectra Medical Devices, LLC initiated a voluntary recall of Lidocaine HCl Injection USP due to lack of assurance of sterility.
Which Products Are Affected
Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, NDC 65282-1605-1, UPC 0365282160515. Affected lots: AE4013 (Exp 1/31/2027); AE5032 & AE5039 (Exp 3/31/2028); AE5104 (Exp 8/31/2028). A total of 210625 ampules are affected. Distributed USA Nationwide by Spectra Medical Devices, LLC, Wilmington, MA. Made in S. Korea.
What You Should Do
Consumers should follow instructions provided in the firm's notification letter regarding the recalled product.
Why This Matters
The recall involves a human prescription drug distributed across the United States under FDA Class II classification.
Source
FDA recall number D-0554-2026
Original source: FDA Official Notice ↗
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