CLASS III Drug recall · Reported 16 Oct 2019 · FDA Enforcement Report
Benazepril HCl Tablets, USP 40 mg recalled by Amneal Pharmaceuticals
Amneal Pharmaceuticals is recalling Benazepril HCl Tablets, USP 40 mg, distributed nationwide in the US. The recall was initiated on 24 Sep 2019 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-0134-2020
- FDA event ID
- 83915
- Recalling firm
- Amneal Pharmaceuticals, Brookhaven, NY
- Manufacturer
- Amneal Pharmaceuticals LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 24 Sep 2019
- FDA classified
- 9 Oct 2019
- Reported
- 16 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Blood Pressure Medication
Timeline
| 24 Sep 2019 | Recall initiated by company | |
| 9 Oct 2019 | Classified by FDA | +15 days |
| 16 Oct 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle
Product as listed by the FDA
Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10
Where it was distributed
Product was distributed to 13 major distributors throughout the United States who may have further distribute the product.
Questions about this recall
Why was it recalled?
Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle
Which lots are affected?
Lot # BB02619A, exp. date 04/2021
Where was it sold?
Product was distributed to 13 major distributors throughout the United States who may have further distribute the product.
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 Amneal Pharmaceuticals
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Estradiol Gel, 0.1%, 0.25 mg, 30-packets recalledEstradiol | Amneal Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg recalled by Amneal PharmaceuticalsPrimidone | Amneal Pharmaceuticals | Other | Nationwide |
| Drug | CLASS I | Magnesium Sulfate in Water for Injection (40mg/mL) IV recalledMagnesium Sulfate | Amneal Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | traMADol Hydrochloride Tablets, USP, 50 mg recalled | Amneal Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 50 mg recalledChlorpromazine Hydrochloride | Amneal Pharmaceuticals | Packaging Defects | Nationwide |
Other Benazepril recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Benazepril HCL Tablet, 5 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Benazepril HCL Tablet, 40 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |