Subpotent Diarrhea Drug Recalled

Edenbridge Pharmaceuticals is recalling 4548 bottles of opium tincture for subpotency, according to the November 8, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects opium tincture (deodorized), 10 mg/mL of anhydrous morphine, packaged in 118-mL bottles (NDC 42799-217-01) from lots 23ZCP1 (Exp. 2/22/26) and 23ZDR1 (Exp. 3/9/26). The drug was manufactured for Edenbridge Pharmaceuticals, Parsippany, New Jersey, and distributed throughout the US.

Edenbridge Pharmaceuticals voluntarily initiated the recall October 20, 2023. The FDA designated the recall Class III on October 30, 2023. Per the classification, use of the affected medication is not likely to cause harm.

Opium Tincture is available with a prescription for the treatment of diarrhea.