Teva Pharmaceuticals recalls 0.1mg fludrocortisone tablets due to impurities exceeding safety limits. Affected lots manufactured in Canada expire 2024. Consumers should check NDC 0555-0997-02 for details.
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Teva Pharmaceuticals is recalling fludrocortisone acetate tablets (0.1mg) because impurities in the product exceed safe levels. This could pose health risks to people using the medication as prescribed.
The tablets contain impurities and unknown substances that exceed the safety limits set for the medication. These impurities could potentially cause health issues if the medication is used as directed.
People with a prescription for fludrocortisone acetate tablets (0.1mg) who own the recalled product. Those with specific medical conditions requiring this medication are most at risk.
Check for the NDC code 0555-0997-02 on the product label. The product was manufactured in Canada with specific lot numbers: CNSDH, CNWVM, CNWWH, CNXKW, CNXKY, CNXMB, CNXMH, CPBTP, CPBTV, expiring between June 2024 and November 2024.
Look for the NDC code 0555-0997-02 on the tablet packaging.
The product contains impurities and unknown substances that exceed the safety limits set for the medication.
The official recall notice does not specify a remedy or action for affected products.
Check for the NDC code 0555-0997-02 on the product label. The product was manufactured in Canada with specific lot numbers expiring between June 2024 and November 2024.
We’ve drafted a message you can send Teva to request your refund or repair — edit it as you like.
Subject: Recall D-0601-2024 — Teva Teva Hello, I own a Teva that is covered by recall D-0601-2024 from Teva. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
