CLASS III ONGOING Drug recall · Reported 28 Jan 2026 · FDA Enforcement Report
Diclofenac Sodium Topical Gel recalled by Cipla USA
Cipla USA is recalling Diclofenac Sodium Topical Gel, 1%, distributed nationwide in the US. The recall was initiated on 22 Dec 2025 and the FDA has classified it as Class III.
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-0291-2026
- FDA event ID
- 98193
- Recalling firm
- Cipla USA, Warren, NJ
- Brand
- Diclofenac Sodium
- Manufacturer
- EXELAN PHARMACEUTICALS INC.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 22 Dec 2025
- FDA classified
- 20 Jan 2026
- Reported
- 28 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 22 Dec 2025 | Recall initiated by company | |
| 20 Jan 2026 | Classified by FDA | +29 days |
| 28 Jan 2026 | 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
Failed PH Specifications
Product as listed by the FDA
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed PH Specifications
Which lots are affected?
Batch XHBG; Exp. 08/31/2027
Where was it sold?
Nationwide in the USA
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 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 Cipla USA
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 30 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
Other Diclofenac recalls
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diclofenac Sodium, Topical Gel, 3% tube recalledDiclofenac Sodium | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Diclofenac Sodium Topical Solution USP, 2% w/w recalledDiclofenac Sodium | Alembic Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Diclofenac Sodium Topical Solution USP, 1.5% w/w recalled | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Diclofenac Sodium Topical Solution USP, 1.5% w/w recalled | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Diclofenac Sodium Topical Solution recalled by Direct Rx | Direct Rx | Packaging Defects | Nationwide |