← FDA ENFORCEMENT
D-0520-2026Class II

JB Chemicals and Pharmaceuticals Ltd

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
JB Chemicals and Pharmaceuticals Ltd
Product type
Drug
Status
Ongoing
Report date
2026-05-13
Distribution
Nationwide in the USA
Product quantity
675 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test

Product description

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.

Code / lot info

Lot #: GEH25023, Expires: 6/30/2027

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →