Diclofenac sodium topical recalls
The FDA has published 8 recalls involving Diclofenac sodium topical since 2019. The latest was reported on 27 Apr 2022. Most were for potency & assay. Teligent Pharma has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls8since 2019
Last 12 months0reported
Class I00% of total
Ongoing1latest 27 Apr 2022
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 7 88%Class III 1 13%
Why diclofenac sodium topical is recalled
Companies
By year
Ongoing diclofenac sodium topical recalls
1 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diclofenac Sodium Topical Solution, 5% w/w recalled | Preferred Pharmaceuticals | Potency & Assay | CT, FL, KS |
All diclofenac sodium topical recalls, newest first
8 total| 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 |
| Drug | CLASS II | Diclofenac Sodium Topical Solution USP, 5 w/w recalled | Teligent Pharma | Foreign Material | Nationwide |
| Drug | CLASS II | Diclofenac Sodium Topical Solution USP, 5 w/w recalled | Teligent Pharma | Foreign Material | Nationwide |
| Drug | CLASS III | Diclofenac Sodium Topical Solution, 5% w/w recalled | Ingenus Pharmaceuticals | Packaging Defects | Nationwide |
Should you stop taking Diclofenac sodium topical?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.