Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceutic...

FDA Drug Recall #D-0134-2020 — Class III — September 24, 2019

Recall Summary

Recall Number D-0134-2020
Classification Class III — Low risk
Date Initiated September 24, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Amneal Pharmaceuticals, Inc.
Location Brookhaven, NY
Product Type Drugs
Quantity 9,720 100 count bottles

Product Description

Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10

Reason for Recall

Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle

Distribution Pattern

Product was distributed to 13 major distributors throughout the United States who may have further distribute the product.

Lot / Code Information

Lot # BB02619A, exp. date 04/2021

Other Recalls from Amneal Pharmaceuticals, Inc.

Recall # Classification Product Date
D-0613-2020 Class II Ranitidine Tablets, USP 300 mg - a).30-count bo... Nov 22, 2019
D-0616-2020 Class II Ranitidine Tablets, USP 300 mg, 250-count bottl... Nov 22, 2019
D-0612-2020 Class II Ranitidine Tablets, USP 150 mg a).60-count bot... Nov 22, 2019
D-0615-2020 Class II Ranitidine Tablets, USP 150 mg, 1000-count bott... Nov 22, 2019
D-0614-2020 Class II Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. ... Nov 22, 2019

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.