Severity
Low
FDA Drug recall · Reported February 17, 2016
Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)
Amerisource Health Services recalled Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by… - a low-severity action.
Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by… was recalled by Amerisource Health Services in February 17, 2016. Reason: Failed Impurities/Degradation Specifications; 9 month stability (manufacturer). Check the official notice for the remedy. Verify recall #D-0660-2016 with the FDA Drug before acting.
The recall
Amerisource Health Services issued this low-severity FDA Drug recall-Failed Impurities/Degradation Specifications; 9 month stability (manufacturer).
Sourced from official FDA Drug enforcement records. Verify recall #D-0660-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-0660-2016) was formally reported on February 17, 2016, with the manufacturer initiating the action on January 26, 2016. It is classified under Low severity (Class III), with a current status of Terminated. Amerisource Health Services is listed as the recalling firm, operating out of Columbus, OH. Federal records list the affected scope as 716 cartons.
The documented reason for this recall is: Failed Impurities/Degradation Specifications; 9 month stability (manufacturer) Distribution data in the federal record shows the product reached: Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Low
Affected scope
716 cartons
Related Recalls
6
5 from same agency
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)
Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0660-2016 |
| Date reported | February 17, 2016 |
| Date initiated | January 26, 2016 |
| Recalling firm | Amerisource Health Services |
| Firm location | Columbus, OH |
| Affected scope | 716 cartons |
| Distribution | Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported February 17, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.