CLASS III Drug recall · Reported 8 Nov 2023 · FDA Enforcement Report
Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine recalled
Edenbridge Pharmaceuticals is recalling Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, distributed nationwide in the US. The recall was initiated on 20 Oct 2023 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0080-2024
- FDA event ID
- 93236
- Recalling firm
- Edenbridge Pharmaceuticals, Parsippany, NJ
- Manufacturer
- Edenbridge Pharmaceuticals, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Oct 2023
- FDA classified
- 30 Oct 2023
- Reported
- 8 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 20 Oct 2023 | Recall initiated by company | |
| 30 Oct 2023 | Classified by FDA | +10 days |
| 8 Nov 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine recalled?
Yes. Edenbridge Pharmaceuticals recalled Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine on 20 Oct 2023. The recall is Class III and its status is Terminated. Recall number D-0080-2024.
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot#: 23ZCP1, Exp. Date 02/22/2026;Lot #:23ZDR1, Exp. Date 03/09/2026
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Morphine recalls
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Morphine Sulfate Oral Solution 100 mg / (20 mg* / mL) recalledMorphine Sulfate | Winder Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS II | Morphine Sulfate Extended-Release Tablets, 100 mg recalledMorphine Sulfate | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Morphine Sulfate Extended-Release Tablets 30 mg recalled | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Morphine Sulfate Extended-Release Tablets 15 mg recalled | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |