Stop using nowDrug recall · FDA · Published February 7, 2022
Teligent Pharma Erythromycin Gel Recall: Impurities Risk Serious Injury
Teligent Pharma recalls 30g Erythromycin Topical Gel USP 2% tubes due to impurities that could cause serious injury. Rx-only product manufactured in Buena, NJ. Check NDC 63739-053-66 for affected lots.
“Teligent Pharma Erythromycin Gel Recall: Impurities Risk Serious Injury.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35236-teligent-pharma-erythromycin-gel-recall-impurities-risk-serious-injury. Based on FDA recall #D-0716-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0716-2022%22&limit=1).
The FDA announced on Feb. 7, 2022, that Teligent Pharma, Inc. voluntarily recalled Erythromycin Topical Gel USP due to failed impurity specifications. The agency classified the recall as Class II.
How to tell if you have it
Brand: Teligent Pharma
Product: Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube
NDC: 63739-053-66
Lot: 15724
Expiration: 06/2022
The hazard
The recall addresses lots not meeting specifications for Unknown Max Related Compounds. The FDA classified the issue as a Class II recall.
Context
GovInfoNow's records show Teligent Pharma, Inc. has had 18 other recalls since May 20, 2019. Other recent recalls of similar products include Trifluent Pharma Wound Care Gel Recall (April 8, 2026), OneSource Specialty Pharma Methohexital Sodium Recall (June 7, 2026), and SUN PHARMACEUTICAL Clindamycin Phosphate Topical Solution Recall (Nov. 26, 2025).
How to tell if you have this one
Check for the 30g tube labeled 'Erythromycin Topical Gel USP 2%' with NDC 63739-053-66. The product was manufactured in Buena, NJ and distributed by McKesson in Memphis, TN.
Brand
Teligent Pharma
Category
Drug
Based on the official FDA remedy
What to do — step by step
Stop Using Now
Immediately discard the affected gel product as it contains impurities that could cause serious injury.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
1Firm started the recall
2Published in FDA’s Enforcement Report
3FDA classified it Class II
4FDA terminated the recall
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-0716-2022 (February 7, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0716-2022 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.