The Recall Desk
ModerateFDA (Drugs)·D-1244-2019·Announced 2019-05-01

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

Lupin Pharmaceuticals is recalling specific lots of Morphine Sulfate Extended-Release Tablets because they failed impurity and degradation specifications.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class III recall, which is defined as a situation where violation of labeling or manufacturing regulations is unlikely to cause adverse health consequences. The rubric assigns a score of 2 to Class III recalls.

Plain-English summary

Lupin Pharmaceuticals, Inc. is recalling 15,320 bottles of Morphine Sulfate Extended-Release Tablets, 30 mg. The product is manufactured by Novel Laboratories, Inc. and distributed under the brand name MORPHINE SULFATE. The recall involves specific lots with expiration dates ranging from April 30, 2019, to February 29, 2020.

The recall was initiated because the affected product failed to meet impurities and degradation specifications. This indicates that the chemical composition of the tablets did not conform to the required quality standards for safety and purity.

The product was shipped to five wholesalers and one supermarket chain, which may have further distributed the medication throughout the United States. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be returned to the pharmacy or point of purchase for disposal or replacement.

The recalled product

Product
MORPHINE SULFATE (MORPHINE SULFATE)
Brand
MORPHINE SULFATE
Manufacturer
LUPIN SOMERSET
Category
Drug — Prescription Medication
Hazard
Affected units
15,320

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#: S700221
  • Exp. Apr 30 2019
  • S700605
  • Exp. July 31 2019
  • S800232
  • Exp. Feb 29 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 · impurity

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