FDA Drugs recall ·
Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only… recall
- Recall number
- D-0520-2026
- Date
- (initiated April 23, 2026)
- Company / brand
- JB Chemicals and Pharmaceuticals Ltd
Neelam Centre A Wing A B Wing, Mumbai, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 675 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.
Why was it recalled?
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: GEH25023, Expires: 6/30/2027
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0520-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.