Opium Tincture recalled for subpotent morphine content nationwide
Edenbridge Pharmaceuticals recalled opium tincture nationwide because the morphine concentration fell below labeled potency. The voluntary recall affected 4,548 bottles.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III classification with no reported illnesses or injuries. Subpotency is a quality defect in a controlled substance without reported adverse events. Voluntary, firm-initiated recall justifies a Moderate score per rubric guidance that Class III recalls are typically 1 or 2.
Plain-English summary
Edenbridge Pharmaceuticals has recalled Opium Tincture, USP (Deodorized), 10 mg/mL morphine in 118 mL bottles due to subpotency. The affected lot numbers are 23ZCP1 (expiring 02/22/2026) and 23ZDR1 (expiring 03/09/2026), with 4,548 bottles distributed nationwide.
The recall was initiated on October 20, 2023, after testing revealed that the morphine concentration in the product was below the labeled strength. This was a voluntary, firm-initiated recall, classified by the FDA as Class III.
Patients and healthcare providers who have received affected bottles should not use them and should contact Edenbridge Pharmaceuticals or their pharmacist for replacement product. The recall was terminated on August 16, 2024.
The recalled product
- Product
- OPIUM TINCTURE DEODORIZED (MORPHINE)
- Brand
- OPIUM TINCTURE DEODORIZED
- Manufacturer
- Edenbridge Pharmaceuticals, LLC
- Category
- Drug — Opioid
- Hazard
- Affected units
- 4,548
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot#: 23ZCP1
- Exp. Date 02/22/2026
- Lot #:23ZDR1
- Exp. Date 03/09/2026
Distribution
Distributed nationwide across the United States.
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