Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054, NDC 42799-217-01
FDA recall notice · announced November 8, 2023 · Edenbridge Pharmaceuticals
Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.
The product
Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054, NDC 42799-217-01
Reason for recall
Subpotent Drug
Notes
Distribution: Nationwide within the United States
Lot/code information: Lot#: 23ZCP1, Exp. Date 02/22/2026;Lot #:23ZDR1, Exp. Date 03/09/2026
Quantity: 4548 bottles
Status: Terminated
Products in this recall event:
- Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054, NDC 42799-217-0 (D-0080-2024)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.