Merck Recalls Liptruzet Tablets Due to Defective Outer Packaging
Merck is recalling Liptruzet tablets because defective outer foil pouches may allow air and moisture to enter, potentially affecting product effectiveness.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is limited to potential loss of effectiveness due to packaging defects.
Plain-English summary
Merck & Co. is recalling 11,462 cartons of Liptruzet (ezetimibe and atorvastin) tablets, 10 mg/80 mg. The recall involves 30-count and 90-count blister packs distributed nationwide and in Puerto Rico.
The recall is due to defective outer laminate foil pouches that allowed air and moisture to enter. This defect could potentially decrease the effectiveness or change the characteristics of the product.
Patients and consumers should check their medication for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled items, they should contact their healthcare provider or pharmacist for guidance on replacement or discontinuation.
The recalled product
- Product
- Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister (NDC 66582-323-30), b) 90 count blister (NDC 66582-323-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
- Manufacturer
- Merck & Co Inc
- Category
- Drug — Prescription Medication
- Affected units
- 11,462
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 (9)
- a) Liptruzet 10/80mg 30 count
- 346379
- 350257
- Exp.07/14
- 353591
- Exp. 06/15. b) Liptruzet 10/80mg 90 count
- 346383
- 371072
- Exp. 06/15.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Merck & Co Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Merck & Co Inc
See all →- ModerateBelsomra 10 mg tablets failed dissolution, which may delay sleep onset
FDA (Drugs) · 2025-08-20
- LowMerck Recalls Liptruzet Tablets Due to Packaging Defects
FDA (Drugs) · 2014-05-14
- LowMerck Recalls Liptruzet Tablets Due to Packaging Defects
FDA (Drugs) · 2014-05-14
- LowMerck Recalls Liptruzet Tablets Due to Packaging Defects
FDA (Drugs) · 2014-05-14
Same hazard · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- SevereMerck Recalls Vytorin Tablets Due to Foreign Tablet Presence
FDA (Drugs) · 2015-10-14
- ModeratePfizer Recalls Caduet Tablets Due to Defective Bottle Seals
FDA (Drugs) · 2020-02-19
- SevereImpax Recalls Lamotrigine Tablets Due to Labeling Mixup
FDA (Drugs) · 2016-12-28
- ModerateWockhardt Recalls Azithromycin Tablets Due to Complaint Investigation Failures
FDA (Drugs) · 2015-07-29
- ModerateAmerican Health Packaging Recalls Azithromycin Tablets Due to CGMP Deviations
FDA (Drugs) · 2015-07-15
- ModerateAvKARE Recalls Lamotrigine Tablets Due to Foreign Substance Presence
FDA (Drugs) · 2020-06-10