Lower risk Drug recall · FDA · Published October 19, 2021

Teligent Pharma Diclofenac Topical Solution Recall: Defective Container Hazard

Teligent Pharma recalls 1.5% diclofenac topical solution bottles due to defective container risk. Rx-only product with specific lot numbers and expiration dates.

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

🇺🇸 FDA recall #D-0259-2022Drug Teligent Pharma ›

Lower-risk recall

Defective Container

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Teligent Pharma is recalling diclofenac sodium topical solution bottles because the container may be defective. This could lead to improper storage or handling risks for users who need this prescription medication. Read more at govinfonow.com/recall/35641-teligent-pharma-diclofenac-topical-solution-recall-defective-container-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/35641-teligent-pharma-diclofenac-topical-solution-recall-defective-container-hazard · Updated August 18, 2026 · FDA enforcement record: FDA #D-0259-2022

Cite this page

“Teligent Pharma Diclofenac Topical Solution Recall: Defective Container Hazard.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35641-teligent-pharma-diclofenac-topical-solution-recall-defective-container-hazard. Based on FDA recall #D-0259-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0259-2022%22&limit=1).

The FDA announced on 2021-10-19 that Teligent Pharma, Inc. voluntarily recalled Diclofenac Sodium Topical Solution USP due to a defective container hazard. The recall affects 5,400 units distributed nationwide.

How to tell if you have it

Brand: Teligent Pharma
Product: Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles
NDC: 70512-025-05
Lot codes: 15028 (Exp 1/2023), 15379 (Exp 3/2023)
Quantity: 5,400 units

The hazard

The recall is due to a defective container for the prescription drug. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Teligent Pharma, Inc. has had 18 other recalls on record since 2019-05-20. Other recent recalls of similar products include Cipla Diclofenac Gel Recall (2025-12-22), Sun Pharmaceutical Diclofenac Gel Recall (2026-01-27), and Keystone DHP Topical Anesthetic Gel Recall (2026-05-21).

How to tell if you have this one

Check for plastic bottles labeled 'Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL)' with lot numbers 15028 (expiring 1/2023) or 15379 (expiring 3/2023).

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 II
Status
Terminated
Distribution
Nationwide within the United States

Recall number	Product, codes & lots	Quantity
D-0258-2022	Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 52565-002-05; Lot #: 15188, Exp 2/2023	2664 bottles
D-0259-2022	Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 70512-025-05.; Lot #: 15028, Exp 1/2023; 15379, Exp 3/2023.	5400 units

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the lot number and expiration date on the bottle to confirm if it's in the recall list.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within 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 2.7 years after the firm started it.

Oct 19, 2021Firm started the recall
Nov 23, 2021FDA classified it Class II
Dec 1, 2021Published in FDA’s Enforcement Report
Jun 18, 2024FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/35641-teligent-pharma-diclofenac-topical-solution-recall-defective-container-hazard">Teligent Pharma Diclofenac Topical Solution Recall: Defective Container Hazard (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-0259-2022 (October 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0259-2022 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.