The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0081-2019·Announced 2018-10-03

Hetero Labs Recalls Montelukast Sodium Tablets Due to Labeling Error

Hetero Labs Limited is recalling 98,016 bottles of Montelukast Sodium 10 mg tablets because one lot may contain Losartan Potassium 50 mg tablets.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The rubric mandates a score of 5 for FDA Class I recalls.

Plain-English summary

Hetero Labs Limited Unit V is recalling 98,016 bottles of Montelukast Sodium Tablets 10 mg, 30-count, prescription-only. The product is manufactured in India for Camber Pharmaceuticals, Inc. The recall involves Lot # MON17384 with an expiration date of 12/19.

The recall was initiated due to a labeling mix-up. One lot labeled as Montelukast Sodium Tablets 10 mg may contain 90 tablets of Losartan Potassium 50 mg. This discrepancy means patients may receive a different medication than prescribed.

The affected product was distributed nationwide in the U.S.A. Consumers and healthcare providers should check their medication for the specific lot number and expiration date. If the medication matches the recalled lot, it should be returned to the pharmacy or contact the manufacturer for instructions.

The recalled product

Product
MONTELUKAST SODIUM (MONTELUKAST SODIUM)
Brand
MONTELUKAST SODIUM
Manufacturer
Hetero Labs Limited Unit V
Category
Drug — Prescription Drug
Hazard
Affected units
98,016

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 #: MON17384
  • Exp 12/19

UPCs (1)

  • 0331722726306

Distribution

Distributed nationwide across the United States.

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