Opium Tincture — Class III drug recall D-0080-2024
Terminated recall by Edenbridge Pharmaceuticals, LLC, reported 2023-11-08, distributed nationwide. Subpotent Drug
| Recall number | D-0080-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edenbridge Pharmaceuticals, LLC, Parsippany, NJ, United States |
| Recall initiated | 2023-10-20 |
| Classified | 2023-10-30 |
| Reported by FDA | 2023-11-08 |
| Terminated | 2024-08-16 |
| Distributed | Nationwide (US) |
| Quantity | 4,548 bottles |
| Reason classes | potency |
| NDC | 42799-0217, 42799-0217-01, 42799-0217-02 |
| Lot numbers | 23ZCP1, 23ZDR1 |
| Expiration dates | 2026-02-22, 2026-03-09 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0080-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.