CLASS I Drug recall · Reported 17 Apr 2019 · FDA Enforcement Report
Lidocaine HCl Injection, USP 1 % 50 mg/ (10 mg/mL) vial recalled
Aurobindo Pharma USA is recalling Lidocaine HCl Injection, USP 1 % 50 mg/ (10 mg/mL) vial, distributed in North Carolina, New Mexico. The recall was initiated on 28 Mar 2019 and the FDA has classified it as Class I.
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-1248-2019
- FDA event ID
- 82496
- Recalling firm
- Aurobindo Pharma USA, East Windsor, NJ
- Brand
- Marbeta L Kit
- Manufacturer
- Asclemed USA, Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 28 Mar 2019
- FDA classified
- 25 Apr 2019
- Reported
- 17 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Pain Medication
Timeline
| 28 Mar 2019 | Recall initiated by company | |
| 17 Apr 2019 | Published in enforcement report | +20 days |
| 25 Apr 2019 | Classified by FDA | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: One vial was found to contain a hair.
Product as listed by the FDA
Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India for: AuroMedics Pharna LLC. E Windsor, NJ 08520 NDC 55150-162-05
Where it was distributed
Product is being held at a distributor site in Mexico, Asheboro, NC, Charlotte, NC and Santa Teresa, NM and not further distributed in the U.S. Market.
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: One vial was found to contain a hair.
Which lots are affected?
Lot #: CLC180117, Exp. June 2021
Where was it sold?
Product is being held at a distributor site in Mexico, Asheboro, NC, Charlotte, NC and Santa Teresa, NM and not further distributed in the U.S. Market.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 6 Oct 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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