FDA recall, , Moderate risk
Rising Pharma Enalapril Maleate Tablets
Enalapril Maleate Tablets failed impurities/degradation specifications due to an out-of-specification result in organic impurities test.
Summary by Recall Canary from the FDA notice
What happened
JB Chemicals and Pharmaceuticals Ltd, based in Mumbai, India, recalled Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottles, distributed by Rising Pharma Holdings, Inc., East Brunswick, NJ. The recall was initiated on April 23, 2026, because the product failed impurities/degradation specifications due to an out-of-specification result in the organic impurities test.
The recall involved 675 bottles and was distributed nationwide in the USA. The FDA added the recall to its Enforcement Report on May 5, 2026, and it was listed in the weekly enforcement report on May 13, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your bottle affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle
- NDC
- 64980-688-10
- Lot code
- GEH25023
Recall details
- Company began the recall
- Sold in
Nationwide in the USA
- Company
- JB Chemicals and Pharmaceuticals LtdMumbai, India
- Hazard
- Drug impurity
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98794
- Recall number
- D-0520-2026
- Quantity recalled
- 675 bottles
All recalls from JB Chemicals and Pharmaceuticals Ltd
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
