Severity
Low
FDA Drug recall · Reported September 24, 2014
Failed Impurity/Degradation Specification; high out of specification for CAD II degradant
Apotex Corp. recalled Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx… - a low-severity action.
Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx… was recalled by Apotex Corp. in September 24, 2014. Reason: Failed Impurity/Degradation Specification; high out of specification for CAD II degradant. Check the official notice for the remedy. Verify recall #D-1570-2014 with the FDA Drug before acting.
The recall
Apotex Corp. issued this low-severity FDA Drug recall-Failed Impurity/Degradation Specification; high out of specification for CAD II degradant.
Sourced from official FDA Drug enforcement records. Verify recall #D-1570-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-1570-2014) was formally reported on September 24, 2014, with the manufacturer initiating the action on August 21, 2014. It is classified under Low severity (Class III), with a current status of Terminated. Apotex Corp. is listed as the recalling firm, operating out of Weston, FL. Federal records list the affected scope as 1,494 bottles.
The documented reason for this recall is: Failed Impurity/Degradation Specification; high out of specification for CAD II degradant 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
1,494 bottles
Related Recalls
6
5 from same agency
Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex Research Pvt. Ltd. Bangalore - 560 099, India NDC 60505-3759-9
Failed Impurity/Degradation Specification; high out of specification for CAD II degradant
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-1570-2014 |
| Date reported | September 24, 2014 |
| Date initiated | August 21, 2014 |
| Recalling firm | Apotex Corp. |
| Firm location | Weston, FL |
| Affected scope | 1,494 bottles |
| 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 September 24, 2014. 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.