Apotex Recalls Candesartan Cilexetil and Hydrochlorothiazide Tablets Due to Impurity
Apotex Corp. is recalling Candesartan Cilexetil and Hydrochlorothiazide Tablets because a specific degradant exceeded safety specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Apotex Corp. is recalling 1,494 bottles of Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles. The product is prescription-only and was distributed nationwide. The specific lot affected is # KK6086, with an expiration date of 03/2015 and UPC 360505375998.
The recall was initiated because the product failed an impurity/degradation specification. Specifically, the CAD II degradant was found to be high out of specification. The FDA has classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or supplier for disposal or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- 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
- Manufacturer
- Apotex Corp.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,494
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # KK6086
- exp 03/2015
- UPC 360505375998.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Apotex Corp.
See all →- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
- ModerateApotek desmopressin nasal spray recalled over dislodged or missing cap liners
FDA (Drugs) · 2026-04-22
- HighBrimonidine and timolol eye drops recalled over sterility assurance failure
FDA (Drugs) · 2026-03-25
- HighKetorolac ophthalmic solution recalled over sterility assurance and bottle sealing concerns
FDA (Drugs) · 2025-10-08
- HighGlaucoma eye drops recalled over sterility assurance and bottle sealing concerns
FDA (Drugs) · 2025-10-08
Same hazard · impurity
See all →- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17