Why it was recalled
Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.
Product description
Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-982-01
Lot numbers, UPCs & expiration codes
Lot #: Q900580, Exp 9/2021
Where it was sold
U.S.A. Nationwide
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-1079-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 1, 2020
- FDA report date
- Apr 8, 2020
- Quantity
- 25,944 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1079-2020, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 85355
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot #: Q900580, Exp 9/2021
- Postal code
- 21202-6174
- Report date
- Apr 8, 2020
- Product type
- Drugs
- Recall number
- D-1079-2020
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 25,944 bottles
- Termination date
- Jun 30, 2021
- Reason for recall
- Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-982-01
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Apr 1, 2020
- Initial firm notification
- Letter
- Center classification date
- Apr 2, 2020