Hetero Recalls Montelukast Sodium Tablets Due to Blue Specks
Hetero Labs Limited is recalling 98,016 bottles of Montelukast Sodium 10 mg tablets because a pharmacist reported blue specks on the tablets.
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 II, which typically involves a reasonable probability of temporary or medically reversible health consequences. The hazard is a cosmetic defect (discoloration) without reported illness or injury, fitting the 'Moderate' criteria for minor labeling or quality errors.
Plain-English summary
Hetero Labs Limited Unit V is recalling 98,016 bottles of Montelukast Sodium Tablets, 10 mg, 30-count bottles. The product is a prescription-only medication manufactured in India for Camber Pharmaceuticals, Inc. The affected lot is MON17355 with an expiration date of 12/19.
The recall was initiated after a pharmacist reported the presence of blue specks on the tablets. This discoloration indicates a potential quality issue with the product. The affected bottles were distributed nationwide in the USA.
Consumers who have this specific lot of Montelukast Sodium should stop using it and contact their healthcare provider or pharmacist for guidance. The product should be returned to the pharmacy or disposed of according to local regulations.
The recalled product
- Product
- MONTELUKAST SODIUM (MONTELUKAST SODIUM)
- Brand
- MONTELUKAST SODIUM
- Manufacturer
- Hetero Labs Limited Unit V
- Category
- Drug — Prescription Medication
- 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 #: MON17355
- Exp 12/19
UPCs (1)
- 0331722726306
Distribution
Distributed nationwide across the United States.
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