Class II · Moderate risk
Enalapril Maleate Tablets
CGMP Deviations
Enalapril Maleate Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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.
Affected NDC
64980-0688-10
Compare with the code on your package — it is the most precise check available.
Drug: Enalapril Category: Blood Pressure Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Enalapril Maleate NDC 64980-0688 |
20 mg/1 | Tablet Oral |
Rising Pharma Holdings, Inc. | Rx |
- Recalling firm
- JB Chemicals and Pharmaceuticals Ltd
- NDC code
- 64980-688-10
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0520-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Enalapril recalls
See all
Class II · Moderate risk
Enalapril Maleate Tablets
CGMP Deviations
Class II · Moderate risk
Enalapril Maleate Tablets
CGMP Deviations
Class II · Moderate risk
Enalapril Maleate Tablets
CGMP Deviations
Class II · Moderate risk
Enalapril Maleate Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other recalls by JB Chemicals and Pharmaceuticals Ltd
All 2026 recalls
Class I · High risk
Cetirizine Hydrochloride Tablets USP 5 mg
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
Class III · Low risk
Cetirizine Hydrochloride Tablets USP 10 mg
Tablet/Capsules Imprinted with Wrong ID
Class III · Low risk
Cetirizine Hydrochloride Tablets USP 10 mg
Tablet/Capsules Imprinted with Wrong ID
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.