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 code: 363481684030 NDC code: 6348168403) and 5/100-g tubes/packs (UPC code: 363481684054 NDC code: 6348168405), Marketed by Endo Pharmaceuticals Inc., Chadds Ford, PA and Manufactured by Novartis Consumer Health, Inc, Parsippany, NJ.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot #'s and Expiration dates: a) 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: 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 10085248 3/31/2013 10085249 3/31/2013 10085260 3/31/2013 10085261 3/31/2013 10085262 3/31/2013 10085263 3/31/2013 10085264 3/31/2013 10085265 3/31/2013 10085266 3/31/2013 10085267 3/31/2013 10085268 3/31/2013 10085269 3/31/2013 10085270 3/31/2013 10085271 3/31/2013 10085272 3/31/2013 10087039 3/31/2013 10087040 3/31/2013 10087041 3/31/2013 10087042 3/31/2013 10087043 3/31/2013 10087052 3/31/2013 10087053 3/31/2013 10087054 3/31/2013 10087055 3/31/2013 10087063 3/31/2013 10087064 3/31/2013 10087065 3/31/2013 10088276 4/30/2013 10088277 4/30/2013 10088278 4/30/2013 10088279 4/30/2013 10088280 4/30/2013 10088281 4/30/2013 10088282 4/30/2013 10088289 4/30/2013 10088290 4/30/2013 10088291 4/30/2013 10088292 4/30/2013 10088293 4/30/2013 10088294 4/30/2013 10088295 4/30/2013 10088296 4/30/2013 10088297 4/30/2013 10088298 4/30/2013 10088299 4/30/2013 10088300 4/30/2013 10088301 4/30/2013 10088302 4/30/2013 10088303 4/30/2013 10088304 4/30/2013 10088305 4/30/2013 10088306 4/30/2013 10088307 4/30/2013 10088308 4/30/2013 10088309 4/30/2013 10088310 4/30/2013 10088311 4/30/2013 10088312 4/30/2013 10088313 4/30/2013 10088314 4/30/2013 10088315 4/30/2013 10088897 5/31/2013 10088898 5/31/2013 10088899 5/31/2013 10088900 5/31/2013 10088901 5/31/2013 10088902 5/31/2013 10088903 5/31/2013 10088904 5/31/2013 10088905 5/31/2013 10088906 5/31/2013 10088907 5/31/2013 10088908 5/31/2013 10088909 5/31/2013 10088910 5/31/2013 10088911 6/30/2013 10088921 7/31/2013 10088922 7/31/2013 10088923 7/31/2013 10088924 7/31/2013 10088925 7/31/2013 10088926 7/31/2013 10088927 7/31/2013 10088928 7/31/2013 10088929 7/31/2013 10088930 7/31/2013 10088931 7/31/2013 10090306 4/30/2013 10090307 4/30/2013 10090308 4/30/2013 10092277 7/31/2013 10092278 7/31/2013 10092279 7/31/2013 10092280 7/31/2013 10092281 7/31/2013 10092282 7/31/2013 10092283 7/31/2013 10092284 8/31/2013 10092285 8/31/2013 10092288 8/31/2013 10092289 8/31/2013 10092290 8/31/2013 10092291 8/31/2013 10092292 8/31/2013 10092293 8/31/2013 10092294 8/31/2013 10094387 8/31/2013 10094388 8/31/2013 10094389 8/31/2013 10094390 8/31/2013 10094394 9/30/2013 10094395 9/30/2013 10094396 9/30/2013 10094397 9/30/2013 10094398 9/30/2013 10097030 9/30/2013 10097031 9/30/2013 10097032 9/30/2013 10097033 9/30/2013 10097035 10/31/2013 10097036 10/31/2013 10098681 10/31/2013 10098692 10/31/2013 10098693 10/31/2013 10098694 10/31/2013 10098695 10/31/2013 10098697 10/31/2013 10098698 10/31/2013 10098699 10/31/2013 10098700 10/31/2013 10098701 10/31/2013 10098702 10/31/2013 10098703 10/31/2013 10098704 10/31/2013 10098708 11/30/2013 10098709 11/30/2013 10100515 11/30/2013 10100516 11/30/2013 10100517 11/30/2013 10100524 12/31/2013 10100525 12/31/2013 10100526 12/31/2013 10100527 12/31/2013 10100528 12/31/2013 10102312 12/31/2013 10102313 12/31/2013 10102314 12/31/2013 10102315 12/31/2013 10102316 12/31/2013 10102317 12/31/2013 10102318 12/31/2013 10102319 1/31/2014 10102320 1/31/2014 10102321 1/31/2014 10102322 1/31/2014 10102323 1/31/2014 10102324 1/31/2014 10102325 1/31/2014 10102326 1/31/2014 10102328 1/31/2014 10102329 1/31/2014 10102330 1/31/2014 10102331 1/31/2014 10102332 1/31/2014 10102337 1/31/2014 10102338 1/31/2014 10104246 2/28/2014 10104247 2/28/2014 10104248 2/28/2014 10104249 2/28/2014 10104250 2/28/2014 10104251 2/28/2014 10104252 2/28/2014 10104257 2/28/2014 10104258 2/28/2014 10104259 2/28/2014 10104260 2/28/2014 10104261 2/28/2014 10104262 2/28/2014 10107735 2/28/2014 10107736 3/31/2014 10107737 3/31/2014 10107738 3/31/2014 10107739 3/31/2014 10107740 3/31/2014 10107741 3/31/2014 10107749 3/31/2014 10107750 3/31/2014 10107751 3/31/2014 10107752 3/31/2014 10107753 3/31/2014 10107754 3/31/2014 10110430 4/30/2014 10110431 4/30/2014 10110432 4/30/2014 10110433 4/30/2014 10110434 4/30/2014 10110435 4/30/2014 10110436 4/30/2014 10110437 4/30/2014 10110438 4/30/2014 10110439 4/30/2014 10110440 4/30/2014 10110441 4/30/2014 10110442 4/30/2014 10110443 4/30/2014 10110444 4/30/2014 10111080 4/30/2014 10111081 4/30/2014 10111082 5/31/2014 10111083 5/31/2014 10113475 5/31/2014 10113476 5/31/2014 10113477 5/31/2014 10113478 5/31/2014 10113479 5/31/2014 10113480 5/31/2014 10113481 5/31/2014 10113482 5/31/2014 10113483 5/31/2014 10113484 5/31/2014 10113485 6/30/2014 10113486 6/30/2014 10113487 6/30/2014 10113488 6/30/2014 10113489 6/30/2014 10113490 6/30/2014 10115859 6/30/2014 10115860 6/30/2014 10115861 6/30/2014 10115862 6/30/2014 10115863 6/30/2014 10115864 6/30/2014 10115865 6/30/2014 10115866 6/30/2014 10115867 6/30/2014 10115868 6/30/2014 10115869 6/30/2014 10115870 6/30/2014 10115871 7/31/2014 10115872 7/31/2014 10115873 7/31/2014 10115876 7/31/2014 10115877 7/31/2014 10115878 7/31/2014 10117411 7/31/2014 10117413 7/31/2014 10117414 7/31/2014 10117416 7/31/2014 10117417 7/31/2014 10119416 9/30/2014 10119417 9/30/2014 10119418 9/30/2014 10119419 9/30/2014 10119420 9/30/2014 10119429 9/30/2014 10119430 9/30/2014 10119431 9/30/2014 10119432 9/30/2014 10119433 10/31/2014 10119434 10/31/2014 10120546 8/31/2014 10120547 8/31/2014 10120548 8/31/2014 10120549 8/31/2014 10120550 8/31/2014 10120551 8/31/2014 10120552 8/31/2014 10120553 8/31/2014 10120554 8/31/2014 10120555 9/30/2014 10120556 9/30/2014 10120557 9/30/2014 10120558 9/30/2014 100 gm/5 pack: 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 10088914 6/30/2013 10088915 6/30/2013 10088916 6/30/2013 10088917 6/30/2013 10088918 6/30/2013 10088919 6/30/2013 10088920 7/31/2013 10092286 8/31/2013 10092287 8/31/2013 10094391 8/31/2013 10094392 8/31/2013 10094393 9/30/2013 10097029 9/30/2013 10097034 9/30/2013 10098696 10/31/2013 10098705 10/31/2013 10098706 10/31/2013 10098707 11/30/2013 10100518 11/30/2013 10100519 11/30/2013 10100520 11/30/2013 10100521 11/30/2013 10100522 12/31/2013 10100523 12/31/2013 10102327 1/31/2014 10102333 1/31/2014 10102334 1/31/2014 10102335 1/31/2014 10102336 1/31/2014 10104253 2/28/2014 10104254 2/28/2014 10104255 2/28/2014 10104256 2/28/2014 10107742 3/31/2014 10107743 3/31/2014 10107744 3/31/2014 10107745 3/31/2014 10107746 3/31/2014 10107747 3/31/2014 10107748 3/31/2014 10111084 5/31/2014 10111085 5/31/2014 10111086 5/31/2014 10111087 5/31/2014 10111088 5/31/2014 10111089 5/31/2014 10111090 5/31/2014 10115874 7/31/2014 10115875 7/31/2014 10117412 7/31/2014 10117415 7/31/2014 10119409 7/31/2014 10119410 7/31/2014 10119411 7/31/2014 10119412 8/31/2014 10119413 8/31/2014 10119414 8/31/2014 10119415 8/31/2014 10119435 10/31/2014 10119436 10/31/2014
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Novartis Consumer Health
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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 code: 363481684030 NDC code: 6348168403) and 5/100-g tubes/packs (UPC code: 363481684054 NDC code: 6348168405), Marketed by Endo Pharmaceuticals Inc., Chadds Ford, PA and Manufactured by Novartis Consumer Health, Inc, Parsippany, NJ.

Product Codes/Lot Numbers:

Lot #'s and Expiration dates: a) 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: 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 10085248 3/31/2013 10085249 3/31/2013 10085260 3/31/2013 10085261 3/31/2013 10085262 3/31/2013 10085263 3/31/2013 10085264 3/31/2013 10085265 3/31/2013 10085266 3/31/2013 10085267 3/31/2013 10085268 3/31/2013 10085269 3/31/2013 10085270 3/31/2013 10085271 3/31/2013 10085272 3/31/2013 10087039 3/31/2013 10087040 3/31/2013 10087041 3/31/2013 10087042 3/31/2013 10087043 3/31/2013 10087052 3/31/2013 10087053 3/31/2013 10087054 3/31/2013 10087055 3/31/2013 10087063 3/31/2013 10087064 3/31/2013 10087065 3/31/2013 10088276 4/30/2013 10088277 4/30/2013 10088278 4/30/2013 10088279 4/30/2013 10088280 4/30/2013 10088281 4/30/2013 10088282 4/30/2013 10088289 4/30/2013 10088290 4/30/2013 10088291 4/30/2013 10088292 4/30/2013 10088293 4/30/2013 10088294 4/30/2013 10088295 4/30/2013 10088296 4/30/2013 10088297 4/30/2013 10088298 4/30/2013 10088299 4/30/2013 10088300 4/30/2013 10088301 4/30/2013 10088302 4/30/2013 10088303 4/30/2013 10088304 4/30/2013 10088305 4/30/2013 10088306 4/30/2013 10088307 4/30/2013 10088308 4/30/2013 10088309 4/30/2013 10088310 4/30/2013 10088311 4/30/2013 10088312 4/30/2013 10088313 4/30/2013 10088314 4/30/2013 10088315 4/30/2013 10088897 5/31/2013 10088898 5/31/2013 10088899 5/31/2013 10088900 5/31/2013 10088901 5/31/2013 10088902 5/31/2013 10088903 5/31/2013 10088904 5/31/2013 10088905 5/31/2013 10088906 5/31/2013 10088907 5/31/2013 10088908 5/31/2013 10088909 5/31/2013 10088910 5/31/2013 10088911 6/30/2013 10088921 7/31/2013 10088922 7/31/2013 10088923 7/31/2013 10088924 7/31/2013 10088925 7/31/2013 10088926 7/31/2013 10088927 7/31/2013 10088928 7/31/2013 10088929 7/31/2013 10088930 7/31/2013 10088931 7/31/2013 10090306 4/30/2013 10090307 4/30/2013 10090308 4/30/2013 10092277 7/31/2013 10092278 7/31/2013 10092279 7/31/2013 10092280 7/31/2013 10092281 7/31/2013 10092282 7/31/2013 10092283 7/31/2013 10092284 8/31/2013 10092285 8/31/2013 10092288 8/31/2013 10092289 8/31/2013 10092290 8/31/2013 10092291 8/31/2013 10092292 8/31/2013 10092293 8/31/2013 10092294 8/31/2013 10094387 8/31/2013 10094388 8/31/2013 10094389 8/31/2013 10094390 8/31/2013 10094394 9/30/2013 10094395 9/30/2013 10094396 9/30/2013 10094397 9/30/2013 10094398 9/30/2013 10097030 9/30/2013 10097031 9/30/2013 10097032 9/30/2013 10097033 9/30/2013 10097035 10/31/2013 10097036 10/31/2013 10098681 10/31/2013 10098692 10/31/2013 10098693 10/31/2013 10098694 10/31/2013 10098695 10/31/2013 10098697 10/31/2013 10098698 10/31/2013 10098699 10/31/2013 10098700 10/31/2013 10098701 10/31/2013 10098702 10/31/2013 10098703 10/31/2013 10098704 10/31/2013 10098708 11/30/2013 10098709 11/30/2013 10100515 11/30/2013 10100516 11/30/2013 10100517 11/30/2013 10100524 12/31/2013 10100525 12/31/2013 10100526 12/31/2013 10100527 12/31/2013 10100528 12/31/2013 10102312 12/31/2013 10102313 12/31/2013 10102314 12/31/2013 10102315 12/31/2013 10102316 12/31/2013 10102317 12/31/2013 10102318 12/31/2013 10102319 1/31/2014 10102320 1/31/2014 10102321 1/31/2014 10102322 1/31/2014 10102323 1/31/2014 10102324 1/31/2014 10102325 1/31/2014 10102326 1/31/2014 10102328 1/31/2014 10102329 1/31/2014 10102330 1/31/2014 10102331 1/31/2014 10102332 1/31/2014 10102337 1/31/2014 10102338 1/31/2014 10104246 2/28/2014 10104247 2/28/2014 10104248 2/28/2014 10104249 2/28/2014 10104250 2/28/2014 10104251 2/28/2014 10104252 2/28/2014 10104257 2/28/2014 10104258 2/28/2014 10104259 2/28/2014 10104260 2/28/2014 10104261 2/28/2014 10104262 2/28/2014 10107735 2/28/2014 10107736 3/31/2014 10107737 3/31/2014 10107738 3/31/2014 10107739 3/31/2014 10107740 3/31/2014 10107741 3/31/2014 10107749 3/31/2014 10107750 3/31/2014 10107751 3/31/2014 10107752 3/31/2014 10107753 3/31/2014 10107754 3/31/2014 10110430 4/30/2014 10110431 4/30/2014 10110432 4/30/2014 10110433 4/30/2014 10110434 4/30/2014 10110435 4/30/2014 10110436 4/30/2014 10110437 4/30/2014 10110438 4/30/2014 10110439 4/30/2014 10110440 4/30/2014 10110441 4/30/2014 10110442 4/30/2014 10110443 4/30/2014 10110444 4/30/2014 10111080 4/30/2014 10111081 4/30/2014 10111082 5/31/2014 10111083 5/31/2014 10113475 5/31/2014 10113476 5/31/2014 10113477 5/31/2014 10113478 5/31/2014 10113479 5/31/2014 10113480 5/31/2014 10113481 5/31/2014 10113482 5/31/2014 10113483 5/31/2014 10113484 5/31/2014 10113485 6/30/2014 10113486 6/30/2014 10113487 6/30/2014 10113488 6/30/2014 10113489 6/30/2014 10113490 6/30/2014 10115859 6/30/2014 10115860 6/30/2014 10115861 6/30/2014 10115862 6/30/2014 10115863 6/30/2014 10115864 6/30/2014 10115865 6/30/2014 10115866 6/30/2014 10115867 6/30/2014 10115868 6/30/2014 10115869 6/30/2014 10115870 6/30/2014 10115871 7/31/2014 10115872 7/31/2014 10115873 7/31/2014 10115876 7/31/2014 10115877 7/31/2014 10115878 7/31/2014 10117411 7/31/2014 10117413 7/31/2014 10117414 7/31/2014 10117416 7/31/2014 10117417 7/31/2014 10119416 9/30/2014 10119417 9/30/2014 10119418 9/30/2014 10119419 9/30/2014 10119420 9/30/2014 10119429 9/30/2014 10119430 9/30/2014 10119431 9/30/2014 10119432 9/30/2014 10119433 10/31/2014 10119434 10/31/2014 10120546 8/31/2014 10120547 8/31/2014 10120548 8/31/2014 10120549 8/31/2014 10120550 8/31/2014 10120551 8/31/2014 10120552 8/31/2014 10120553 8/31/2014 10120554 8/31/2014 10120555 9/30/2014 10120556 9/30/2014 10120557 9/30/2014 10120558 9/30/2014 100 gm/5 pack: 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 10088914 6/30/2013 10088915 6/30/2013 10088916 6/30/2013 10088917 6/30/2013 10088918 6/30/2013 10088919 6/30/2013 10088920 7/31/2013 10092286 8/31/2013 10092287 8/31/2013 10094391 8/31/2013 10094392 8/31/2013 10094393 9/30/2013 10097029 9/30/2013 10097034 9/30/2013 10098696 10/31/2013 10098705 10/31/2013 10098706 10/31/2013 10098707 11/30/2013 10100518 11/30/2013 10100519 11/30/2013 10100520 11/30/2013 10100521 11/30/2013 10100522 12/31/2013 10100523 12/31/2013 10102327 1/31/2014 10102333 1/31/2014 10102334 1/31/2014 10102335 1/31/2014 10102336 1/31/2014 10104253 2/28/2014 10104254 2/28/2014 10104255 2/28/2014 10104256 2/28/2014 10107742 3/31/2014 10107743 3/31/2014 10107744 3/31/2014 10107745 3/31/2014 10107746 3/31/2014 10107747 3/31/2014 10107748 3/31/2014 10111084 5/31/2014 10111085 5/31/2014 10111086 5/31/2014 10111087 5/31/2014 10111088 5/31/2014 10111089 5/31/2014 10111090 5/31/2014 10115874 7/31/2014 10115875 7/31/2014 10117412 7/31/2014 10117415 7/31/2014 10119409 7/31/2014 10119410 7/31/2014 10119411 7/31/2014 10119412 8/31/2014 10119413 8/31/2014 10119414 8/31/2014 10119415 8/31/2014 10119435 10/31/2014 10119436 10/31/2014

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-577-2013

Related Recalls

The products are being recalled due to the receipt of a relatively high number of consumer complaints.

Dec 18, 2013 Dietary Supplements Nationwide View Details →

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Jun 18, 2013 Over-the-Counter Nationwide View Details →

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Jun 18, 2013 Over-the-Counter Nationwide View Details →