FDAClass IIINovember 8, 2023

Opium Tincture recall: Subpotent

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

Why was Opium Tincture recalled?

Subpotent Drug

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot#: 23ZCP1, Exp. Date 02/22/2026;Lot #:23ZDR1, Exp. Date 03/09/2026

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
Recalling firm
Edenbridge Pharmaceuticals, LLC
Quantity
4548 bottles
Distribution
Nationwide within the United States
Recall date
November 8, 2023
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls