The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0280-2022·Announced 2021-12-22

Lidocaine Topical Solution Recalled for Superpotency

Teligent Pharma, Inc. is recalling Lidocaine Hydrochloride Topical Solution USP 4% nationwide due to the drug being superpotent. Affected lots are 13262 (Exp. 03/2022) and 14217 (Exp. 08/2022).

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA's Class I classification applies, which mandates a minimum severity score of 4 per the rubric. Although no specific injuries or hospitalizations are reported in the source text, a superpotent drug product carries inherent risk of serious harm, meeting the Severe category threshold.

Plain-English summary

Teligent Pharma, Inc. is recalling Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) in 50 mL glass bottles nationwide. The firm initiated this voluntary recall because the affected drug product has been determined to be superpotent. A total of 52,104 glass bottles are affected, with NDC 52565-009-50.

The affected lot numbers are 13262 with an expiration date of 03/2022 and lot 14217 with an expiration date of 08/2022. The product is a prescription-only topical anesthetic solution.

Patients and healthcare providers who have received this product should contact Teligent Pharma, Inc. or their healthcare provider for guidance. The FDA classified this as a Class I recall, indicating a situation in which there is a reasonable probability that the use of, or exposure to, the product will cause serious adverse health consequences or death.

The recalled product

Product
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Anesthetic
Hazard
Affected units
52,104

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot #: 13262
  • Exp. 03/2022
  • 14217
  • Exp. 08/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Teligent Pharma, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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