The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0088-2019·Announced 2018-10-17

GSK Recalls Prevacid 24HR Capsules Due to Manufacturing Deviations

GSK is voluntarily recalling Prevacid 24HR capsules nationwide due to Current Good Manufacturing Practice (CGMP) deviations. No illnesses have been reported.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 II due to CGMP deviations, but no illnesses or injuries have been reported, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

GlaxoSmithKline Nebraska is voluntarily recalling Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, in 1-, 2-, and 3-bottle cartons. The recall was initiated on September 26, 2018, and affects approximately 5.5 million bottles distributed nationwide in the United States and Puerto Rico.

The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations. The FDA has classified this recall as Class II, which indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. No illnesses or adverse events have been reported in connection with this recall.

Consumers who have purchased these products should check their lot numbers and expiration dates against the list provided by the manufacturer. If the product matches the recalled lots, consumers should stop using it and contact GSK Consumer Healthcare for a refund or replacement.

The recalled product

Product
Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per bottle in a carton containing 1 bottle (NDC: 0067-6286-14), 2 bottles (NDC: 0067-6286-28) or 3 bottles (NDC: 0067-6286-42), Over-the-counter, Distributed By: GSK Consumer Healthcare, Warren, NJ 07059.
Manufacturer
GLAXOSMITHKLINE NEBRASKA
Category
Drug — Over-the-Counter Medication
Hazard
Affected units
5,548,673

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 (20)

  • 1-bottle cartons lot #: GE2743
  • GE4570
  • GG0536
  • Exp 9/30/2018
  • GE3445
  • GG4810
  • Exp 11/30/2018
  • A38M
  • Exp 12/31/2018
  • K63J
  • Exp 4/30/2018
  • H24T
  • Exp 5/31/2018
  • RS4U
  • M721601MA
  • Exp 7/31/2018
  • 379H
  • Exp 8/31/2018
  • A93E
  • AE2S

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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