Unrated Drug recall · FDA · Published June 22, 2021

Teligent Pharma Erythromycin Gel Recall: Failed Impurities Risk

Teligent Pharma recalls 2% Erythromycin Topical Gel (30g/60g) due to failed impurities. Rx-only products with specific NDCs and lots may pose risks. Consumers should contact for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0690-2021Drug Teligent Pharma ›

Recall notice

Failed Impurities/Degradation Specifications

Take action

Contact the company

Recalling firmTeligent Pharma, Inc.105 Lincoln Avenue · Buena, NJ 08310

✎ GovInfoNow plain-language explainer

Teligent Pharma is recalling 2% Erythromycin Topical Gel (30g and 60g sizes) because the product failed impurities and degradation specifications. This is a prescription-only medication that could pose risks if used improperly. Read more at govinfonow.com/recall/36109-teligent-pharma-erythromycin-gel-recall-failed-impurities-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/36109-teligent-pharma-erythromycin-gel-recall-failed-impurities-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0690-2021

Cite this page

“Teligent Pharma Erythromycin Gel Recall: Failed Impurities Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/36109-teligent-pharma-erythromycin-gel-recall-failed-impurities-risk. Based on FDA recall #D-0690-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0690-2021%22&limit=1).

The FDA announced on June 22, 2021, that Teligent Pharma, Inc. voluntarily recalled Erythromycin Topical Gel due to failed impurity specifications. The recall affects 22,824 tubes distributed nationwide.

How to tell if you have it

Brand: Teligent Pharma
Product: Erythromycin Topical Gel, 2%
NDC 52565-033-30, Lot 14010, Exp July 2021
NDC 52565-033-60, Lot 13865, Exp June 2021
NDC 52565-033-60, Lot 14011, Exp July 2021

The hazard

The product failed impurity and degradation specifications. The FDA classified the recall as Class III.

Context

GovInfoNow's records show Teligent Pharma, Inc. has had 18 other recalls since May 20, 2019. Other recent recalls of similar products include SUN PHARMACEUTICAL Clindamycin Phosphate Topical Solution Recall (2025-11-26), Fresenius Kabi Epinephrine Injection Recall (2026-05-14), and Trifluent Pharma Wound Care Gel Recall (2026-04-08).

How to tell if you have this one

Check the product label for 'Erythromycin Topical Gel, 2%' with sizes 30g or 60g. Look for NDC numbers 52565-033-30 (lot 14010, expires July 2021) or 52565-033-60 (lots 13865 or 14011, expire June or July 2021).

Brand
Teligent Pharma
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class III
Status
Terminated
Distribution
Nationwide

Recall number	Product, codes & lots	Quantity
D-0689-2021	Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310, NDC 52565-027-59; Lot 14180	7872 tubes
D-0690-2021	Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(NDC 52565-033-60) Rx Only, Manufactured by: Teligent Pharma, Inc. , Buena, NJ 08310,; 1) NDC 52565-033-30 Lot 14010, Exp July 2021; 2) NDC 52565-033-60 Lot 13865, Exp June 2021; Lot 14011, Exp July 2021.	22,824 tubes

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the NDC numbers 52565-033-30 or 52565-033-60 on the label to confirm if your product is recalled.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3 years after the firm started it.

Jun 22, 2021Firm started the recall
Jul 19, 2021FDA classified it Class III
Jul 28, 2021Published in FDA’s Enforcement Report
Jul 3, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/36109-teligent-pharma-erythromycin-gel-recall-failed-impurities-risk">Teligent Pharma Erythromycin Gel Recall: Failed Impurities Risk (GovInfoNow)</a>

Where this comes from

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-0690-2021 (June 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0690-2021 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.