Cardinal Health Recalls Metoprolol Tartrate and Hydrochlorothiazide Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling 71 bottles of Metoprolol Tartrate and Hydrochlorothiazide tablets due to intermittent temperature excursions during storage.
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: The recall is classified as FDA Class II, which typically indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a CGMP deviation (temperature excursion) without reported injuries or illnesses, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Cardinal Health Inc. is recalling 71 bottles of Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg. The product is identified by NDC 62332-115-31 and was manufactured for Alembic Pharmaceuticals, Inc.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. This condition may affect the stability or quality of the medication.
The affected product was distributed in Florida, Georgia, and South Carolina. Patients and healthcare providers should discontinue use of the recalled product and contact their healthcare provider for alternative treatment options. Consumers should return the product to the pharmacy or point of purchase.
The recalled product
- Product
- METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE (METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE)
- Brand
- METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 71
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)
- 2005005745
UPCs (1)
- 0362332115303
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health 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.
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