CLASS III Drug recall · Reported 14 May 2014 · FDA Enforcement Report

Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg recalled

Merck is recalling Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) blister (, distributed nationwide in the US. The recall was initiated on 13 Jan 2014 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesa) 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.

Quantity recalled11,462 cartons

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1312-2014
FDA event ID: 67344
Recalling firm: Merck, Whitehouse Station, NJ
Classification: Class III
Status: Terminated
Recall initiated: 13 Jan 2014
FDA classified: 6 May 2014
Reported: 14 May 2014
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Drug class: Cholesterol Medication

Timeline

13 Jan 2014	Recall initiated by company
6 May 2014	Classified by FDA	+113 days
14 May 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.

Product as listed by the FDA

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

Where it was distributed

Nationwide and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.

Which lots are affected?

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.

Where was it sold?

Nationwide and Puerto Rico

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 67344

This product is part of a recall event; the main page for the event is Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg recalled.

Reported	Class	Recall	Company	Reason	Where
14 May 2014	CLASS III	Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg recalled	Merck	Packaging Defects	Nationwide
14 May 2014	CLASS III	Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg recalled	Merck	Packaging Defects	Nationwide
14 May 2014	CLASS III	Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg recalled	Merck	Packaging Defects	Nationwide

More recalls from Merck

All 5

Reported	Class	Recall	Company	Reason	Where
20 Aug 2025Drug	CLASS II	Belsomra (suvorexant) tablets, 10mg in 3 Blister Cards recalledBelsomra	Merck	Potency & Assay	Nationwide
14 May 2014Drug	CLASS III	Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg recalled	Merck	Packaging Defects	Nationwide
14 May 2014Drug	CLASS III	Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg recalled	Merck	Packaging Defects	Nationwide
14 May 2014Drug	CLASS III	Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg recalled	Merck	Packaging Defects	Nationwide

Other Liptruzet (ezetimibe recalls

All 4

Reported	Class	Recall	Company	Reason	Where
14 May 2014Drug	CLASS III	Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg recalled	Merck	Packaging Defects	Nationwide
14 May 2014Drug	CLASS III	Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg recalled	Merck	Packaging Defects	Nationwide
14 May 2014Drug	CLASS III	Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg recalled	Merck	Packaging Defects	Nationwide