Amerisource Health Services Candesartan Cilexetil Tablets Recall

Why it was recalled

Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)

Product description

Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by: American Health Packaging Columbus, Ohio 43217, NDC 68084-877-25(carton), NDC 68084-877-95(individual dose)

Lot numbers, UPCs & expiration codes

Lot # 153855, exp 01/2017

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0660-2016
Classification: Class III
Status: Terminated
Recall initiated: Jan 26, 2016
FDA report date: Feb 17, 2016
Quantity: 716 cartons
Recall type: Voluntary: Firm initiated
Recalling firm: Amerisource Health Services

Original FDA data

Every field from FDA enforcement report D-0660-2016, exactly as published.

Show all FDA fields

City: Columbus
State: OH
Status: Terminated
Country: United States
Event ID: 73166
Address: 2550 John Glenn Ave
Address (line 2): Suite A
Code information: Lot # 153855, exp 01/2017
Postal code: 43217-1188
Report date: Feb 17, 2016
Product type: Drugs
Recall number: D-0660-2016
Classification: Class III
Recalling firm: Amerisource Health Services
Product quantity: 716 cartons
Termination date: Jan 11, 2017
Reason for recall: Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)
Voluntary / mandated: Voluntary: Firm initiated
Product description: Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by: American Health Packaging Columbus, Ohio 43217, NDC 68084-877-25(carton), NDC 68084-877-95(individual dose)
Distribution pattern: Nationwide
Recall initiation date: Jan 26, 2016
Initial firm notification: Letter
Center classification date: Feb 11, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0660-2016, published Feb 17, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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