CLASS III Drug recall · Reported 17 Feb 2016 · FDA Enforcement Report
Candesartan Cilexetil Tablets, 16 mg (5 x, Rx recalled
Amerisource Health Services is recalling Candesartan Cilexetil Tablets, 16 mg (5 x, Rx, distributed nationwide in the US. The recall was initiated on 26 Jan 2016 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0660-2016
- FDA event ID
- 73166
- Recalling firm
- Amerisource Health Services, Columbus, OH
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 26 Jan 2016
- FDA classified
- 11 Feb 2016
- Reported
- 17 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 26 Jan 2016 | Recall initiated by company | |
| 11 Feb 2016 | Classified by FDA | +16 days |
| 17 Feb 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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)
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)
Which lots are affected?
Lot # 153855, exp 01/2017
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Amerisource Health Services
All 69| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Primidone Tablets, USP, 250 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) [] recalledMeclizine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride, Capsules, USP, 1 mg recalledPrazosin Hydrochloride | Amerisource Health Services | Nitrosamine Impurity | Nationwide |
Other Candesartan Cilexetil recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Candesartan Cilexetil Tablets, USP 16 mg recalled by ViatrisCandesartan Cilexetil | Viatris | Potency & Assay | Nationwide |
| Drug | CLASS III | Candesartan Cilexetil and Hydrochlorothiazide Tablets recalledCandesartan Cilexetil And Hydrochlorothiazide | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Candesartan Cilexetil Tablets, 16 mg, a) recalled by Sandoz | Sandoz | Potency & Assay | Nationwide |
| Drug | CLASS III | candesartan cilexetil, tablets, 16 mg recalled by Sandoz | Sandoz | Potency & Assay | Nationwide |
| Drug | CLASS III | Candesartan Cilexetil Tablets, 8 mg recalled by Apotex | Apotex | Potency & Assay | Nationwide |