FDA Drug recall D-0080-2024
Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbrid…
- FDA Drug
- Class III
- terminated
- Published 2023-11-08
On 2023-11-08 the FDA classified a Class III recall of Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbrid… by Edenbridge Pharmaceuticals, citing subpotent Drug.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0080-2024 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2023-10-20 |
| Published | 2023-11-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Edenbridge Pharmaceuticals |
| Distribution | US |
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
Subpotent Drug
Identifiers
| ndc | 42799-217-01 |
|---|---|
| ndc | 42799-217-02 |
| code_info | Lot#: 23ZCP1, Exp. Date 02/22/2026;Lot #:23ZDR1, Exp. Date 03/09/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0080-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.