CLASS II Drug recall · Reported 17 Feb 2021 · FDA Enforcement Report
Lidocaine/Tetracaine (LIPO110)* 23%/7% Ointment 100 GMS recalled
Stanley Specialty Pharmacy Compounding and Wellness Center is recalling Lidocaine/Tetracaine (LIPO110)* 23%/7% Ointment 100 GMS per, distributed nationwide in the US. The recall was initiated on 21 Jan 2021 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-0252-2021
- FDA event ID
- 87255
- Recalling firm
- Stanley Specialty Pharmacy Compounding and Wellness Center, Charlotte, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jan 2021
- FDA classified
- 10 Feb 2021
- Reported
- 17 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 21 Jan 2021 | Recall initiated by company | |
| 10 Feb 2021 | Classified by FDA | +20 days |
| 17 Feb 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent Drug. Lidocaine higher concentration than listed
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Lidocaine/Tetracaine (LIPO110)* 23%/7% Ointment 100 GMS per 4 ounce plastic ointment jar, Rx Only, Stanley Specialty Pharmacy 3120 Latrobe Dr. Suite 200 Charlotte, NC 28211
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Superpotent Drug. Lidocaine higher concentration than listed
Which lots are affected?
Lot: 195789 Exp. Apr. 17 2021
Where was it sold?
Distributed 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.
Other Lidocaine recalls
All 119| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS III | Lidolog Kit, Kit Contains: Lidocaine HCl Injection recalledLidolog Kit | Asclemed USA | Other | TN |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Lidocaine HCl Injection USP, 1% (10 mg/mL) single dose ampule recalledLidocaine Hydrochloride | Asclemed USA | Sterility | Nationwide |