Why it was recalled
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.
Lot numbers, UPCs & expiration codes
Lot #: GEH25023, Expires: 6/30/2027
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0520-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 23, 2026
- FDA report date
- May 13, 2026
- Quantity
- 675 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- JB Chemicals and Pharmaceuticals Ltd
Original FDA data
Every field from FDA enforcement report D-0520-2026, exactly as published.
Show all FDA fields
- City
- Mumbai
- Status
- Ongoing
- Country
- India
- Event ID
- 98794
- Address
- Neelam Centre A Wing A B Wing
- Address (line 2)
- 4th Floor; Hind Cycle Road
- Code information
- Lot #: GEH25023, Expires: 6/30/2027
- Report date
- May 13, 2026
- Product type
- Drugs
- Recall number
- D-0520-2026
- Classification
- Class II
- Recalling firm
- JB Chemicals and Pharmaceuticals Ltd
- Product quantity
- 675 bottles
- Reason for recall
- Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 23, 2026
- Initial firm notification
- Letter
- Center classification date
- May 5, 2026