Cardinal Health recalls Synjardy 12.5/1000 mg tablets due to potential temperature exposure during storage. This may affect drug stability but does not cause immediate harm.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cardinal Health is recalling Synjardy (empagliflozin and metformin hydrochloride) tablets because they may have been exposed to temperature changes during storage. This could affect the drug's stability but does not pose an immediate risk to users.
The tablets may have been exposed to temperature fluctuations during storage, which could affect their stability. This is a manufacturing issue related to how the product was stored, not a safety issue for the user.
People who have prescription Synjardy tablets with NDC 0597-0168-69 are affected. Those with diabetes who take this medication are most at risk.
Check for Synjardy tablets labeled 12.5 mg/1000 mg with NDC 0597-0168-69. These were distributed by Boehringer Ingelheim in the US.
Look for the NDC code 0597-0168-69 on the Synjardy tablet packaging.
No, this recall is for potential stability issues due to storage conditions, not an immediate safety risk.
No, the recall does not require stopping use; it's a stability concern that doesn't affect safety.
Check for the NDC code 0597-0168-69 on the Synjardy tablet packaging.
We’ve drafted a message you can send Cardinal Health to request your refund or repair — edit it as you like.
Subject: Recall D-0456-2021 — Cardinal Health Cardinal Health Hello, I own a Cardinal Health that is covered by recall D-0456-2021 from Cardinal Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
