The Recall Desk
LowFDA (Drugs)·D-1243-2019·Announced 2019-05-01

Lupin Recalls Morphine Sulfate Extended-Release Tablets Due to Impurity Failures

Lupin Pharmaceuticals is recalling 17,328 bottles of Morphine Sulfate Extended-Release Tablets because they failed impurity and degradation specifications.

What this means for you

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

Our severity reasoning: The source explicitly identifies this as an FDA Class III recall, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Lupin Pharmaceuticals, Inc. is recalling 17,328 bottles of Morphine Sulfate Extended-Release Tablets, 15 mg. The product is manufactured by Novel Laboratories, Inc. and distributed under NDC 43386-540-01. The recall was initiated because the product failed impurities and degradation specifications.

The affected lots are S700220 (Exp. Apr 30 2019), S700604 (Exp. July 31 2019), and S800326 (Exp. Mar 31 2020). The product was shipped to five wholesalers and one supermarket chain, which may have further distributed the medication throughout the United States.

This is an FDA Class III recall, which indicates that the product is not likely to cause adverse health consequences. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or distributor for disposal.

The recalled product

Product
MORPHINE SULFATE (MORPHINE SULFATE)
Brand
MORPHINE SULFATE
Manufacturer
LUPIN SOMERSET
Category
Drug — Prescription Opioid
Hazard
Affected units
17,328

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 (6)

  • Lot#: S700220
  • Exp. Apr 30 2019
  • S700604
  • Exp. July 31 2019
  • S800326
  • Exp. Mar 31 2020

UPCs (4)

  • 0343386542017
  • 0343386543014
  • 0343386540013
  • 0343386541010

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 5 recalled by LUPIN SOMERSET under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same brand · MORPHINE SULFATE

Same manufacturer · LUPIN SOMERSET

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Same hazard · impurities

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