Lower riskDrug recall · FDA · Published May 14, 2021
Teligent Diflorasone Ointment Recall: Foreign Particles Found
Teligent Pharma recalls 0.05% Diflorasone Diacetate Ointment tubes due to foreign particles detected during stability testing. Rx-only product with NDC numbers 52565-063-15 and 52565-063-30.
“Teligent Diflorasone Ointment Recall: Foreign Particles Found.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/36137-teligent-diflorasone-ointment-recall-foreign-particles-found. Based on FDA recall #D-0636-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0636-2021%22&limit=1).
The Food and Drug Administration announced on May 14, 2021, that Teligent Pharma, Inc. is recalling Diflorasone Diacetate Ointment USP due to foreign particles found during stability testing. The agency classified the recall as Class II.
Foreign particles were observed during routine stability testing of the ointment. The FDA listed the hazard as the presence of a foreign substance.
Context
GovInfoNow's records show Teligent Pharma, Inc. has had 18 other recalls since May 20, 2019. Recent brand actions include a March 15, 2022 recall for cGMP deviations and an Feb. 7, 2022 recall involving impurities in Erythromycin Gel. Other recent recalls of similar products include Graviti Furosemide Tablets Recall (Jan. 10, 2026), Lupin prednisolone acetate ophthalmic suspension recall (June 4, 2026), and Trifluent Pharma Wound Care Gel Recall (April 8, 2026).
How to tell if you have this one
Check for 15g (NDC 52565-063-15) or 30g (NDC 52565-063-30) tubes labeled 'Diflorasone Diacetate Ointment USP 0.05%'. This product is only available by prescription.
Brand
Teligent Pharma
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product's NDC number is 52565-063-15 or 52565-063-30 to confirm it's part of this recall.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-0636-2021 (May 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0636-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.