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Home › FDA recalls › Enalapril Maleate Tablets
CLASS II · ModerateFDA

JB Chemicals and Pharmaceuticals Ltd recalls Enalapril Maleate Tablets

📅 Apr 23, 2026 · 📍 Nationwide
Recalling company
JB Chemicals and Pharmaceuticals Ltd
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.
Reason
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Apr 23, 2026
Reported
May 13, 2026
Distribution
Nationwide in the USA
Status
Ongoing
Quantity
675 bottles
Lot / codes
Lot #: GEH25023, Expires: 6/30/2027
Company location
Mumbai
Recall type
Voluntary: Firm initiated
Recall number
D-0520-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0520-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.