The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-1550-2016·Announced 2016-10-05

Mckesson Recalls Mislabeled Lansoprazole Capsules Due to Labeling Error

Mckesson Packaging Services is recalling 181 cartons of Lansoprazole capsules due to a label mix-up where the outer packaging was mislabeled.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 III, which indicates a low risk of adverse health consequences. The hazard is a labeling error (mis-labeling) without reported injuries, fitting the Moderate severity criteria for minor labeling errors.

Plain-English summary

Mckesson Packaging Services is recalling 181 unit cartons of Lansoprazole Delayed-Release Capsules, USP, 30 mg. The product is packaged in 100-count cartons of 10 x 10 unit dose blister cards and is available by prescription only. The affected lot is # 0111295 with an expiration date of 9/17. The product was distributed nationwide.

The recall was initiated due to a labeling error. The inner packaging was correctly labeled as Omeprazole DR 40mg Capsules, but the outer secondary packaging was mislabeled as Lansoprazole Delayed-Release 30mg Capsules. This discrepancy creates a risk of medication mix-up.

Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or supplier for disposal or replacement. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
Lansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cartons of 10 x 10 unit dose blister cards, Rx only, Manufactured by: Dr. Reddy's Laboratories, Inc., 200 Somerset Corporate Blvd Floor 7, Bridgewater, NJ 08807, NDC 63739-0555-10
Manufacturer
Mckesson Packaging Services
Category
Drug — Prescription Medication
Hazard

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 # 0111295
  • Exp 9/17

Distribution

Distributed nationwide across the United States.

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