The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1214-2018·Announced 2018-09-26

Lupin Recalls Morphine Sulfate Extended-Release Tablets Due to Impurity

Lupin Pharmaceuticals is recalling specific lots of Morphine Sulfate Extended-Release Tablets because testing found an impurity exceeding safety limits.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which indicates the product is unlikely to cause adverse health consequences. The issue is a failed impurity specification without reported injuries or illnesses.

Plain-English summary

Lupin Pharmaceuticals, Inc. is recalling Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles. The affected product is manufactured by Novel Laboratories, Inc. in Somerset, NJ, and distributed nationwide in the U.S. The specific lot number is S800232, with an expiration date of 2/20.

The recall was initiated because the product failed impurity and degradation specifications. Specifically, testing during 3-month stability analysis and retain testing revealed an out-of-specification result for the Morphinone Sulfate impurity.

Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If the product matches the description, it should be returned to the pharmacy or supplier for replacement or refund. Patients should consult their healthcare provider for alternative pain management options if they are currently using this medication.

The recalled product

Product
MORPHINE SULFATE (MORPHINE SULFATE)
Brand
MORPHINE SULFATE
Manufacturer
LUPIN SOMERSET
Category
Drug — Prescription Medication
Hazard
Affected units
4,716

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot# S800232
  • Exp 2/20

UPCs (4)

  • 0343386542017
  • 0343386543014
  • 0343386540013
  • 0343386541010

Distribution

Distributed nationwide across the United States.

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