Morphine Sulfate Oral Solution — Class II drug recall D-1126-2017
Terminated recall by Tris Pharma Inc., reported 2017-09-06, distributed nationwide. Defective container: Oral solution leaking from container.
| Recall number | D-1126-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tris Pharma Inc., Monmouth Junction, NJ, United States |
| Recall initiated | 2017-06-15 |
| Classified | 2017-08-29 |
| Reported by FDA | 2017-09-06 |
| Terminated | 2017-11-08 |
| Distributed | Nationwide (US) |
| Quantity | 34,824 bottles |
| Reason classes | packaging |
| NDC | 27808-0082, 27808-0082-01, 27808-0082-02, 27808-0084, 27808-0084-01, 27808-0084-02 |
| Lot numbers | 08215001A, 08215002A, 08215004A |
| Expiration dates | 2017-06-30, 2017-07-31 |
Product
Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an oral syringe, Rx Only, Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852, NDC 27808-082-01
Reason for recall
Defective container: Oral solution leaking from container.
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-1126-2017. 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.