Drug & Device Safety Atlas

FDA drug recalls · openFDA

Is MORPHINE SULFATE recalled?

The FDA has recorded 3 recalls of MORPHINE SULFATE (2024–2025) , recalled under brands like INFUMORPH 200, MORPHINE SULFATE. 3 still ongoing.

0
Class I (most serious)
2
Class II
1
Class III
3
ongoing

A recall doesn't mean your pills are affected

Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of MORPHINE SULFATE ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.

Why it was recalled

Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton. 1
Failed Dissolution Specifications 1
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual pro 1

The recalls

Class I and ongoing recalls first. Tap a recall for its full record and lot detail.

RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.

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