Enalapril Maleate Tablets recall
FDA recall D-0520-2026 · initiated Apr 23, 2026
JB Chemicals and Pharmaceuticals Ltd recalled Enalapril Maleate Tablets in Apr 2026 — an FDA Class II recall (D-0520-2026) because Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 675 bottles
Details
- 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.
- Recalling company
- JB Chemicals and Pharmaceuticals Ltd
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Apr 23, 2026
- FDA report date
- May 13, 2026
Frequently asked
- Was Enalapril Maleate Tablets recalled?
- JB Chemicals and Pharmaceuticals Ltd recalled Enalapril Maleate Tablets in Apr 2026 — an FDA Class II recall (D-0520-2026) because Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Enalapril Maleate Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0520-2026 was: Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
- Is a recalled Enalapril Maleate Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Enalapril Maleate Tablets are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #: GEH25023, Expires: 6/30/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0520-2026.