FDA Drug recall D-1516-2014
Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby Operations, Ontario, Cana…
- FDA Drug
- Class III
- terminated
- Published 2014-08-13
On 2014-08-13 the FDA classified a Class III recall of Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby Operations, Ontario, Cana… by Novartis Pharmaceuticals, citing failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1516-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-07-30 |
| Published | 2014-08-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Novartis Pharmaceuticals |
| Distribution | US |
Product
Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby Operations, Ontario, Canada L1N 5Z5; Distributed by: Novartis Pharmaceuticals Corp., East Hanover, New Jersey 07936; NDC 0078-0436-05, UPC 3 0078-0436-05 2.
Reason
Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.
Identifiers
| upc | 300780436052 |
|---|---|
| code_info | Lot # PKTS, Exp 01/17 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1516-2014%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.