CLASS II Drug recall · Reported 20 Feb 2019 · FDA Enforcement Report
LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + recalled
US Compounding is recalling LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%) Single Use, distributed nationwide in the US. The recall was initiated on 24 Jan 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0482-2019
- FDA event ID
- 81982
- Recalling firm
- US Compounding, Conway, AR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jan 2019
- FDA classified
- 8 Feb 2019
- Reported
- 20 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 24 Jan 2019 | Recall initiated by company | |
| 8 Feb 2019 | Classified by FDA | +15 days |
| 20 Feb 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date and are printed as Lot# YYYDDYY@XX with a Beyond Use Date: MM/DD/YYY.
Product as listed by the FDA
LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), 3mL Single Use Syringe, Rx only, US Compounding, 1270 Don's Lane, Conway, AR, 800-718-3588, Barcode 62295501303.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date and are printed as Lot# YYYDDYY@XX with a Beyond Use Date: MM/DD/YYY.
Which lots are affected?
Labeled as Lot# YYYDDYY@XX, Beyond Use Date: MM/DD/YYYY.
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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