The Recall Desk
ModerateFDA (Drugs)·D-1247-2019·Announced 2019-05-01

Lupin Recalls Morphine Sulfate Tablets for Impurity Specification 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 indicates a remote possibility of adverse health consequences. The hazard involves failed impurity specifications without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Lupin Pharmaceuticals, Inc. is recalling 324 bottles of Morphine Sulfate Extended-Release Tablets, 200 mg. The affected product was manufactured by Novel Laboratories, Inc. and distributed to five wholesalers and one supermarket chain, which may have further distributed the product throughout the United States.

The recall was initiated because the product failed impurities and degradation specifications. The specific lots involved are S700224 (expiration date April 30, 2019) and S800469 (expiration date March 31, 2020).

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or point of purchase for disposal or replacement in accordance with the recall instructions.

The recalled product

Product
MORPHINE SULFATE (MORPHINE SULFATE)
Brand
MORPHINE SULFATE
Manufacturer
LUPIN SOMERSET
Category
Drug — Prescription Medication
Hazard
Affected units
324

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#: S700224 Exp. Apr 30 2019
  • S800469 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 · impurity

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