The Recall Desk
ModerateFDA (Drugs)·D-1246-2019·Announced 2019-05-01

Lupin Recalls Morphine Sulfate Extended-Release Tablets for Impurity Failures

Lupin Pharmaceuticals is recalling 3,444 bottles of Morphine Sulfate Extended-Release Tablets, 100 mg, due to failed impurities 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 the violation is not likely to cause adverse health consequences. The rubric assigns a score of 2 to minor labeling errors or low-risk contamination, which aligns with the theoretical nature of the impurity failure without reported injuries.

Plain-English summary

Lupin Pharmaceuticals, Inc. is recalling 3,444 bottles of Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles. The product is a prescription-only medication manufactured by Novel Laboratories, Inc. in Somerset, NJ, for Lupin Pharmaceuticals, Inc. in Baltimore, MD. The specific NDC for the recalled product is 43386-543-01.

The recall was initiated because the product failed impurities and degradation specifications. The affected lots are S700223 (Expiration: Apr 30 2019) and S800467 (Expiration: Mar 31 2020). The product was shipped to five wholesalers and one supermarket chain, which may have further distributed the product throughout the United States.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If found, the product should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative pain management options if they have been using this medication.

The recalled product

Product
MORPHINE SULFATE (MORPHINE SULFATE)
Brand
MORPHINE SULFATE
Manufacturer
LUPIN SOMERSET
Category
Drug — Prescription Pain Medication
Hazard
Affected units
3,444

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 (3)

  • Lot#: S700223 Exp. Apr 30 2019
  • S800467
  • 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 →

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Same brand · MORPHINE SULFATE

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Same hazard · impurities

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