FDA Drug recall D-0278-2022
Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc…
- FDA Drug
- Class II
- ongoing
- Published 2021-12-22
On 2021-12-22 the FDA classified a Class II recall of Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc… by Preferred Pharmaceuticals, citing defective container: Out of specification for container integrity leading to bottles leaking.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0278-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-11-29 |
| Published | 2021-12-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Preferred Pharmaceuticals |
| Distribution | CT, FL, KS |
Product
Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01
Reason
Defective container: Out of specification for container integrity leading to bottles leaking.
Identifiers
| code_info | Lot #: E1220B |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0278-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.