UnratedDrug recall · FDA · Published August 3, 2021
Teligent Pharma recalls 4% Lidocaine Topical Solution: Superpotent Drug Risk
Teligent Pharma recalls 4% Lidocaine Hydrochloride Topical Solution (50mL glass bottles) due to superpotent drug risk. Rx-only product with specific lot numbers and expiration date.
“Teligent Pharma recalls 4% Lidocaine Topical Solution: Superpotent Drug Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35992-teligent-pharma-recalls-4-lidocaine-topical-solution-superpotent-drug-risk. Based on FDA recall #D-0800-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0800-2021%22&limit=1).
The FDA announced on Aug. 3, 2021, that Teligent Pharma, Inc. is voluntarily recalling Lidocaine Hydrochloride Topical Solution, USP, 4% due to superpotent drug risks. The recall affects 32,544 glass bottles distributed nationwide in the United States and Canada.
The product is classified as a superpotent drug. The FDA has assigned this recall a Class I classification, indicating the highest risk of adverse health consequences.
Context
GovInfoNow's records show Teligent Pharma, Inc. has had 18 other recalls on record since May 20, 2019. Other recent recalls by the brand include a Halobetasol Ointment recall for cGMP deviations on March 15, 2022, and an Erythromycin Gel recall for impurities risk on Feb. 7, 2022. Other recent recalls of similar products include Spectra Medical Lidocaine Ampules due to sterility risk (May 12, 2026), Asclemed Lidocaine HCl Injection for contaminated medication risk (June 8, 2026), and Keystone DHP Topical Anesthetic Gel for defective container risk (May 21, 2026).
How to tell if you have this one
Check for 4% Lidocaine Hydrochloride Topical Solution in 50mL glass bottles with the lot number 14218 or expiration date 08/2022. The product is prescription-only and sold by Teligent Pharma.
Brand
Teligent Pharma
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product's lot number (14218) and expiration date (08/2022) to confirm if it's recalled.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Nationwide within the United States and Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 50 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0800-2021 (August 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0800-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.