CLASS III Drug recall · Reported 13 Aug 2014 · FDA Enforcement Report
Cataflam (diclofenac potassium) tablets, 50 mg recalled
Novartis Pharmaceuticals is recalling Cataflam (diclofenac potassium) tablets, 50 mg, distributed nationwide in the US. The recall was initiated on 30 Jul 2014 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-1516-2014
- FDA event ID
- 68815
- Recalling firm
- Novartis Pharmaceuticals, Suffern, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 30 Jul 2014
- FDA classified
- 6 Aug 2014
- Reported
- 13 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 30 Jul 2014 | Recall initiated by company | |
| 6 Aug 2014 | Classified by FDA | +7 days |
| 13 Aug 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.
Which lots are affected?
Lot # PKTS, Exp 01/17
Where was it sold?
Nationwide
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.
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