CLASS II Drug recall · Reported 30 Mar 2022 · FDA Enforcement Report
Diclofenac Sodium Topical Solution recalled by Direct Rx
Direct Rx is recalling Diclofenac Sodium Topical Solution 1.5%, distributed nationwide in the US. The recall was initiated on 7 Dec 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-0714-2022
- FDA event ID
- 89807
- Recalling firm
- Direct Rx, Dawsonville, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Dec 2021
- FDA classified
- 22 Mar 2022
- Reported
- 30 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 7 Dec 2021 | Recall initiated by company | |
| 22 Mar 2022 | Classified by FDA | +105 days |
| 30 Mar 2022 | 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: Leaking containers.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 Mfg. For SOLA Pharmaceuticals Baton Rouge, LA, NDC 61919-675-05
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Defective Container: Leaking containers.
Which lots are affected?
Lot #: 24MA2010 Exp. 1/31/2023
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 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 Direct Rx
All 37| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Duloxetine D/R, a) 30 mg recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine D/R, 30 mg, 30 Caps recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine D/R, 20 mg, 30 Caps recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ciprofloxacin Ophth Solution recalled by Direct Rx | Direct Rx | Packaging Defects | 5 states |
| Drug | CLASS II | Ibuprofen 800mg, Generic for: Motrin, Each tablet contains recalled | Direct Rx | Potency & Assay | 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 III | Diclofenac Sodium Topical Gel recalled by Cipla USADiclofenac Sodium | Cipla USA | Other | 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 |