Eszopiclone sleep medication recalled nationwide for shortfill packaging defect
Macleods Pharma USA Inc is recalling Eszopiclone 1 mg tablets due to shortfill—customers reported one to three missing tablets from 30-count bottles. Affected lot BEK2009A (exp. 11/2023) was distributed nationwide and to Puerto Rico.
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: This is an FDA Class II recall involving a packaging defect (shortfill) with no reported illnesses, injuries, or hospitalizations. The hazard is insufficient quantity of product rather than a direct health or safety threat.
Plain-English summary
Macleods Pharma USA Inc has recalled Eszopiclone 1 mg tablets in 30-count bottles due to shortfill—a packaging defect where bottles contain fewer tablets than labeled. Customer complaints identified that affected bottles were missing one to three tablets.
The recalled lot is BEK2009A with an expiration date of November 2023. Approximately 168,690 tablets were distributed nationwide and to Puerto Rico. The product was manufactured by Macleods Pharmaceuticals Ltd. in Baddi, Himachal Pradesh, India, under NDC 33342-299-07.
Consumers who have bottles from the affected lot should contact their pharmacy or doctor with any questions. This is an FDA Class II recall.
The recalled product
- Product
- ESZOPICLONE (ESZOPICLONE)
- Brand
- ESZOPICLONE
- Manufacturer
- Macleods Pharma Usa Inc
- Category
- Drug — Prescription Sleep Aid
- Affected units
- 168,690
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 (1)
- Lot #: BEK2009A Exp: 11/2023
UPCs (3)
- 0333342300119
- 0333342299079
- 0333342301116
Distribution
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