Reported Jun 12, 2013 · Terminated

Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a) Packaged in 20 gm tubes, NDC…

Novartis Consumer Health

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Novartis Consumer Health · 10401 Hwy 6 · Lincoln, NE · 68517-9626

Is this the product you have?

  • Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a) Packaged in 20 gm tubes, NDC 63481-684-83 (physician sample product) and b) 100 gm tubes, NDC 63481-684-47 (the 100 g tubes are also
  • packaged 3/100-g tubes/packs (UPC code363481684030
  • NDC code6348168403)
  • and 5/100-g tubes/packs (UPC code363481684054
  • NDC code6348168405), Marketed by Endo Pharmaceuticals Inc., Chadds Ford, PA and Manufactured by Novartis Consumer Health, Inc, Parsippany, NJ
Lot codes and dates
  • Lot #'s
  • and Expiration datesa) 20
  • gm tubes
    • 10116298
    • 05/31/14
    • 10116299
    • 05/31/14
    • 10116300
    • 05/31/14
    • 10117402
    • 07/31/14
    • 10117403
    • 07/31/14
    • 10117404
    • 08/31/14
    • 10117405
    • 08/31/14
    • 10117406
    • 08/31/14
    • 10117407
    • 10/31/14
    • 10117408
    • 10/31/14
  • b) 100 gm tubes
    • 10119436
    • 10119436
    • 10119437
    • 10119437
    • 10119438
    • 10119438
    • 10119439
    • 10119439
    • 10119440
    • 10119440
    • 10119441
    • 10119441
    • 10119442
    • 10119442
    • 10119443
    • 10119443
    • 10119444
    • 10119444
    • 10119445
    • 10119445
    • 10119446
    • 10119446
    • 100
  • gm/3 pack

    609 of 609 codes

    • 10085217
    • 2/28/2013
    • 10085218
    • 2/28/2013
    • 10085219
    • 2/28/2013
    • 10085220
    • 2/28/2013
    • 10085221
    • 2/28/2013
    • 10085222
    • 2/28/2013
    • 10085223
    • 2/28/2013
    • 10085224
    • 2/28/2013
    • 10085225
    • 2/28/2013
    • 10085226
    • 2/28/2013
    • 10085227
    • 2/28/2013
    • 10085228
    • 2/28/2013
    • 10085229
    • 2/28/2013
    • 10085230
    • 2/28/2013
    • 10085231
    • 2/28/2013
    • 10085232
    • 2/28/2013
    • 10085233
    • 2/28/2013
    • 10085234
    • 2/28/2013
    • 10085235
    • 2/28/2013
    • 10085236
    • 2/28/2013
    • 10085238
    • 2/28/2013
    • 10085239
    • 2/28/2013
    • 10085240
    • 2/28/2013
    • 10085241
    • 2/28/2013
    • 10085242
    • 2/28/2013
    • 10085243
    • 2/28/2013
    • 10085244
    • 2/28/2013
    • 10085245
    • 2/28/2013
    • 10085246
    • 3/31/2013
    • 10085247
    • 3/31/2013
  • gm/5 pack

    180 of 180 codes

    • 10085250
    • 3/31/2013
    • 10085251
    • 3/31/2013
    • 10085252
    • 3/31/2013
    • 10085253
    • 3/31/2013
    • 10085254
    • 3/31/2013
    • 10085255
    • 3/31/2013
    • 10085256
    • 3/31/2013
    • 10085257
    • 3/31/2013
    • 10085258
    • 3/31/2013
    • 10085259
    • 3/31/2013
    • 10087044
    • 3/31/2013
    • 10087048
    • 3/31/2013
    • 10087049
    • 3/31/2013
    • 10087050
    • 3/31/2013
    • 10087051
    • 3/31/2013
    • 10087056
    • 3/31/2013
    • 10087057
    • 3/31/2013
    • 10087058
    • 3/31/2013
    • 10087059
    • 3/31/2013
    • 10087060
    • 3/31/2013
    • 10087061
    • 3/31/2013
    • 10087062
    • 3/31/2013
    • 10088283
    • 4/30/2013
    • 10088284
    • 4/30/2013
    • 10088285
    • 4/30/2013
    • 10088286
    • 4/30/2013
    • 10088287
    • 4/30/2013
    • 10088288
    • 4/30/2013
    • 10088912
    • 6/30/2013
    • 10088913
    • 6/30/2013
Amount recalled
a) 1,043,926 (20-gm) tubes and b) 3,385,481 (100-gm) tubes

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 26, 2014 · Data as of Sep 19, 5:44 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.