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Opiate Recall

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The FDA Safety Information and Adverse Event and Reporting Program is advising healthcare professionals and patients of a potential problem with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health.

Because of problems that occurred when certain products were packaged and labeled at their Lincoln, Nebraska site, tablets from one product may have carried over into the packaging of another product, resulting in the possibility of a stray pill of one medicine being placed in the bottle of another product. This is being done as a precautionary measure, as Endo is not aware of any patient having experienced a confirmed product mix-up, nor any adverse events attributable to a product mix-up.

Affected products are as follows:

  • Opana ER (oxymorphone hydrochloride) Extended-Release Tablets CII
  • Opana (oxymorphone hydrochloride) CII
  • Oxymorphone hydrochloride Tablets CII
  • PERCOCET (oxycodone hydrochloride and acetaminophen USP) Tablets CII
  • PERCODAN (oxycodone hydrochloride and aspirin, USP) Tablets CII
  • ENDOCET (oxycodone hydrochloride and acetaminophen USP) Tablets CII
  • ENDODAN (oxycodone hydrochloride and aspirin, USP) Tablets CII
  • MORPHINE SULFATE Extended-Release Tablets CII
  • ZYDONE (hydrocodone bitartrate/acetaminophen tablets, USP) CIII