RecallRadar

FDA Drug recall D-1126-2017

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, Manufac…

On 2017-09-06 the FDA classified a Class II recall of 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, Manufac… by Tris Pharma, citing defective container: Oral solution leaking from container.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1126-2017
ClassificationClass II
Statusterminated
Initiated2017-06-15
Published2017-09-06
Last updated2026-09-13 11:51 UTC
CompanyTris Pharma
DistributionUS

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

Defective container: Oral solution leaking from container.

Identifiers

ndc27808-084-01
ndc27808-084-02
ndc27808-082-01
ndc27808-082-02
code_infoLot #: 08215001A, Exp 6/30/2017; 08215002A, 08215004A, Exp 7/31/2017

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1126-2017%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.