Lower risk Drug recall · FDA · Published July 30, 2014

Novartis Recalls Cataflam Tablets Due to Illegible Ink

Novartis recalls 50 bottles of Cataflam tablets because ink identification rubbed off, making them illegible. Check your lot numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1516-2014Drug Novartis ›

Lower-risk recall

Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.

Take action

Contact the company

Recalling firmNovartis Pharmaceuticals Corp.25 Old Mill Rd · Suffern, NY 10901-4106

✎ GovInfoNow plain-language explainer

Novartis Pharmaceuticals Corp. is recalling 50 bottles of Cataflam (diclofenac potassium) tablets, 50 mg. The recall was issued because the ink identification on the tablets rubbed off during transit, rendering them illegible for pharmacists and consumers to read. No other defects or injuries have been reported in this record. Read more at govinfonow.com/recall/45925-novartis-pharmaceuticals-corp-recalls-cataflam-diclofenac-potassium-tablets-50-mg.

Source Summary by GovInfoNow · govinfonow.com/recall/45925-novartis-pharmaceuticals-corp-recalls-cataflam-diclofenac-potassium-tablets-50-mg · Updated October 12, 2026 · FDA enforcement record: FDA #D-1516-2014

Cite this page

“Novartis Recalls Cataflam Tablets Due to Illegible Ink.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/45925-novartis-pharmaceuticals-corp-recalls-cataflam-diclofenac-potassium-tablets-50-mg. Based on FDA recall #D-1516-2014 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1516-2014%22&limit=1).

The FDA announced on July 30, 2014, that Novartis Pharmaceuticals Corp. recalled Cataflam (diclofenac potassium) tablets due to ink identification rubbing off during transit. This made the tablets illegible to pharmacists and consumers.

How to tell if you have it

Brand: Novartis
Product: Cataflam Tablets
Description: 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.
Lot #: PKTS
Expiration Date: Exp 01/17
Quantity: 50 bottles

The hazard

The ink identification had rubbed off the tablets in transit, making them illegible to pharmacists and consumers. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show Novartis Pharmaceuticals Corp. has 8 other recalls on record since 2013-08-08. Other recent recalls of similar products include Bionpharma Divalproex Tablets Recall (2026-06-26), Novartis Recalls Diovan 160mg Tablets Due to Failed Dissolution Specifications (2026-08-04), and Unichem Recalls Doxazosin 4mg Tablets Due to Wrong ID Imprint (2026-01-21).

How to tell if you have this one

Check for Cataflam (diclofenac potassium) tablets, 50 mg, in 100-count bottles. Look for NDC 0078-0436-05 and UPC 3 0078-0436-05 2. The affected lot number is PKTS with an expiration date of 01/17.

Brand
Novartis
Product
Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Medication
Verify if you have Cataflam tablets with NDC 0078-0436-05, UPC 3 0078-0436-05 2, lot PKTS, and expiration date 01/17.
Contact Your Pharmacist
If you have these specific bottles, contact your pharmacist or Novartis for further instructions on how to proceed.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 4 months after the firm started it.

Jul 30, 2014Firm started the recall
Aug 6, 2014FDA classified it Class III
Aug 13, 2014Published in FDA’s Enforcement Report
Dec 5, 2014FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Novartis recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/45925-novartis-pharmaceuticals-corp-recalls-cataflam-diclofenac-potassium-tablets-50-mg">Novartis Recalls Cataflam Tablets Due to Illegible Ink (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1516-2014 (July 30, 2014) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1516-2014 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.