Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported April 17, 2019
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
Presence of Particulate Matter: One vial was found to contain a hair.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Aurobindo Pharma USA Inc. recalled Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India… - a critical-severity action.
Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India… was recalled by Aurobindo Pharma USA Inc. in April 17, 2019. Reason: Presence of Particulate Matter: One vial was found to contain a hair.. Check the official notice for the remedy. Verify recall #D-1248-2019 with the FDA Drug before acting.
The recall
Aurobindo Pharma USA Inc. issued this critical-severity FDA Drug recall-Presence of Particulate Matter: One vial was found to contain a hair..
- Critical
- severity level
- Class I
- classification
- April 17, 2019
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1248-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1248-2019) was formally reported on April 17, 2019, with the manufacturer initiating the action on March 28, 2019. It is classified under Critical severity (Class I), with a current status of Terminated. Aurobindo Pharma USA Inc. is listed as the recalling firm, operating out of East Windsor, NJ. Federal records list the affected scope as 88600 vials.
The documented reason for this recall is: Presence of Particulate Matter: One vial was found to contain a hair. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
88600 vials
Related Recalls
6
5 from same agency
Product description
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
Reason for recall
Presence of Particulate Matter: One vial was found to contain a hair.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-1248-2019 |
| Date reported | April 17, 2019 |
| Date initiated | March 28, 2019 |
| Recalling firm | Aurobindo Pharma USA Inc. |
| Firm location | East Windsor, NJ |
| Affected scope | 88600 vials |
| Distribution | 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. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-1248-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Aurobindo Pharma USA Inc.. Units affected: 88600 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: One vial was found to contain a hair.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 17, 2019. Severity: Critical. Recall number: D-1248-2019.
Where was the recalled product distributed? ▼
Distribution: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1248-2019) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported April 17, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.