CLASS II Drug recall · Reported 23 May 2018 · FDA Enforcement Report
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg recalled
Mylan Pharmaceuticals is recalling Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, Mylan Pharmaceuticals, Inc. The recall was initiated on 24 Apr 2018 and the FDA has classified it as Class II.
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-0820-2018
- FDA event ID
- 79957
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Apr 2018
- FDA classified
- 17 May 2018
- Reported
- 23 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Blood Pressure Medication
Timeline
| 24 Apr 2018 | Recall initiated by company | |
| 17 May 2018 | Classified by FDA | +23 days |
| 23 May 2018 | 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
cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
Product as listed by the FDA
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01
Where it was distributed
Product was distributed throughout United States
Questions about this recall
Is Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, Mylan Pharmaceuticals, Inc recalled?
Yes. Mylan Pharmaceuticals recalled Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, Mylan Pharmaceuticals, Inc on 24 Apr 2018. The recall is Class II and its status is Terminated. Recall number D-0820-2018.
Why was it recalled?
cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
Which lots are affected?
Lot Numbers# 3083008 and 3086124, exp Jan 2019
Where was it sold?
Product was distributed throughout 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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Amlodipine and benazapril recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg recalled | Mylan Pharmaceuticals | Manufacturing (CGMP) Deviations | WV |