The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0459-2021·Announced 2021-06-02

Cardinal Health Recalls Synjardy Tablets Due to Temperature Excursions

Cardinal Health is recalling 751 bottles of Synjardy XR tablets distributed in Florida, Georgia, and South Carolina due to intermittent temperature exposure 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when associated with potential adverse health consequences or significant quality deviations like temperature excursions.

Plain-English summary

Cardinal Health Inc. is recalling 751 bottles of Synjardy XR (empagliflozin and metformin hydrochloride) extended-release tablets, 12.5 mg/1000 mg, 60-count bottles. The affected product is identified by code 3190949 and NDC 0597-0300-45. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.

The affected units were distributed to Florida, Georgia, and South Carolina. Synjardy is a prescription medication used for the treatment of type 2 diabetes. The recall is classified as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The recall is being conducted by Cardinal Health Inc., the distributor of the product.

The recalled product

Product
SYNJARDY (EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE)
Brand
SYNJARDY
Manufacturer
Cardinal Health Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
751

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)

  • 3190949

Distribution

Distributed in 3 states:

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.

See all 198 products in this recall →

Related recalls

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Same hazard · temperature excursion

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