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Medication Safety Alerts

Hydrochlorothiazide 12.5 mg Tablets Voluntary Recall

August 27, 2018

On August 27, 2018, the United States Food and Drug Administration (FDA) issued a notice regarding a voluntary recall of hydrochlorothiazide 12.5 mg tablets manufactured by Accord Healthcare Inc. This recall was issued because a bottle of hydrochlorothiazide 12.5 mg tablets contained spironolactone 25 mg tablets. Using spironolactone tablets instead of hydrochlorothiazide tablets can cause hyperkalemia (increase potassium levels) in certain individuals resulting in serious side effects that range from limited health consequences to life-threatening situations in certain individuals.

This may represent a potential health hazard or safety risk to plan members who may be using product affected by this recall.

Hydrochlorothiazide 12.5 mg tablets are light orange to peach colored, round, biconvex tablets with H on one side and 1 on the other side. If your product does not match this description, do not continue to use this product. If you are unsure, contact your pharmacy or doctor for confirmation. If your product is affected by this recall, please contact the pharmacy that filled your prescription for further instructions.

You should not continue to use product that is affected by this recall. Please call your doctor right away for advice if you may be using affected product. Your doctor is familiar with your medical history and can suggest the best treatment option for you. If you need a prescription for a different medicine, please call your doctor.

CVS Caremark Response: If you are currently taking hydrochlorothiazide 12.5 mg tablets and have questions about this recall, please call a Customer Care representative toll-free at 1-866-823-5184. We will give you more information and help with arrangements for the return and replacement of any affected product.

If you are currently taking hydrochlorothiazide 12.5 mg tablets and have questions regarding this recall, please call your doctor or call Accord Healthcare toll-free at 1-855-869-1081, Monday through Friday, 8:00 am to 5:00 pm (ET). You may also call the FDA consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit www.fda.gov/Safety/Recalls/ucm618583.htm.

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