CLASS II Drug recall · Reported 1 Dec 2021 · FDA Enforcement Report
Diclofenac Sodium Topical Solution USP, 5 w/w recalled
Teligent Pharma is recalling Diclofenac Sodium Topical Solution USP, 5 w/w, distributed nationwide in the US. The recall was initiated on 19 Oct 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0259-2022
- FDA event ID
- 88884
- Recalling firm
- Teligent Pharma, Buena, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Oct 2021
- FDA classified
- 23 Nov 2021
- Reported
- 1 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Pain Medication
Timeline
| 19 Oct 2021 | Recall initiated by company | |
| 23 Nov 2021 | Classified by FDA | +35 days |
| 1 Dec 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Diclofenac Sodium Topical Solution USP, 5 w/w recalled?
Yes. Teligent Pharma recalled Diclofenac Sodium Topical Solution USP, 5 w/w on 19 Oct 2021. The recall is Class II and its status is Terminated. Recall number D-0259-2022.
Why was it recalled?
Defective Container
Which lots are affected?
Lot #: 15028, Exp 1/2023; 15379, Exp 3/2023.
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Teligent Pharma
All 63| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gentamicin Sulfate Cream recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Econazole Nitrate Cream recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluocinonide Topical Solution recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluocinonide Gel recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Diflorasone Diacetate Ointment recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
Other Diclofenac sodium topical recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diclofenac Sodium Topical Solution 5% w/w, Generic for Pennsaid recalled | Preferred Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Diclofenac Sodium Topical Solution USP, 5% w/w recalled | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Diclofenac Sodium Topical Solution USP, 5% w/w recalled | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Diclofenac Sodium Topical Solution recalled by Direct Rx | Direct Rx | Packaging Defects | Nationwide |
| Drug | CLASS II | Diclofenac Sodium Topical Solution, 5% w/w recalled | Preferred Pharmaceuticals | Potency & Assay | CT, FL, KS |