The Recall Desk
ModerateFDA (Drugs)·D-1245-2019·Announced 2019-05-01

Lupin Recalls Morphine Sulfate Extended-Release Tablets for Impurity Failures

Lupin Pharmaceuticals is recalling 10,284 bottles of Morphine Sulfate Extended-Release Tablets, 60 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 recall is classified as FDA Class III, which indicates the violation is not likely to cause adverse health consequences. The hazard involves failed impurities and degradation specifications, which is a quality control issue rather than a direct, immediate safety threat like contamination or mislabeling of a common allergen.

Plain-English summary

Lupin Pharmaceuticals, Inc. is recalling 10,284 bottles of Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles. The product is a prescription-only medication manufactured by Novel Laboratories, Inc. in Somerset, NJ, and distributed by Lupin Pharmaceuticals, Inc. in Baltimore, MD. The recall is being conducted because the product failed impurities and degradation specifications.

The affected product is identified by NDC 43386-542-01. The recall includes two specific lots: Lot S700222 with an expiration date of April 30, 2019, and Lot S800233 with an expiration date of February 29, 2020. The product was shipped to five wholesalers and one supermarket chain, who may have further distributed the product throughout the United States.

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 point of purchase for disposal or credit. Patients currently taking this medication should consult their healthcare provider for alternative treatment options.

The recalled product

Product
MORPHINE SULFATE (MORPHINE SULFATE)
Brand
MORPHINE SULFATE
Manufacturer
LUPIN SOMERSET
Category
Drug — Prescription Medication
Hazard
Affected units
10,284

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#: S700222 Exp. Apr 30 2019
  • S800233 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 →

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Same brand · MORPHINE SULFATE

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Same hazard · impurities

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