King Pharmaceuticals Inc., a wholly owned subsidiary of Pfizer Inc, has voluntarily recalled from US wholesalers and retailers all dosage forms of EMBEDA® (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules CII because a prespecified stability requirement was not met during routine testing.
Available data suggest that the issue is unlikely to pose a safety risk to patients using EMBEDA as prescribed. We continue to monitor this issue.
Pfizer Inc is committed to making EMBEDA available to physicians and patients as soon as possible once this stability issue is resolved. We apologize for any inconvenience that this recall may cause.
To report an adverse health consequence or product complaint, please call 1-800-438-1985.