CLASS III Drug recall · Reported 28 Oct 2020 · FDA Enforcement Report
Candesartan Cilexetil and Hydrochlorothiazide Tablets recalled
Mylan Pharmaceuticals is recalling Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, distributed nationwide in the US. The recall was initiated on 2 Oct 2020 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-0049-2021
- FDA event ID
- 86520
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 2 Oct 2020
- FDA classified
- 22 Oct 2020
- Reported
- 28 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 2 Oct 2020 | Recall initiated by company | |
| 22 Oct 2020 | Classified by FDA | +20 days |
| 28 Oct 2020 | 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
Out-of-specification organic impurity results obtained during routine stability testing.
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 and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-count bottles (NDC 0378-3002-05), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Out-of-specification organic impurity results obtained during routine stability testing.
Which lots are affected?
Lot #: a) 8095666, Exp. Date July 2021 b) 3104664, Exp. Date July 2021
Where was it sold?
Nationwide within the United States
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 Mylan Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Acamprosate Calcium, Delayed-Release Tablets, 333 mg recalledAcamprosate Calcium | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem | Mylan Pharmaceuticals | Potency & Assay | 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 Tablets, 16 mg, a) recalled by Sandoz | Sandoz | Potency & Assay | Nationwide |
| Drug | CLASS III | Candesartan Cilexetil Tablets, 16 mg (5 x, Rx recalled | Amerisource Health Services | 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 |