Why it was recalled
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Product description
Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-980-03
Lot numbers, UPCs & expiration codes
Lot # Q201182, exp. date March 2024
Where it was sold
Product was distributed to major distributors/wholesalers 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-1536-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 13, 2022
- FDA report date
- Sep 21, 2022
- Quantity
- 11,802 1000-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1536-2022, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 90859
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot # Q201182, exp. date March 2024
- Postal code
- 21202-6174
- Report date
- Sep 21, 2022
- Product type
- Drugs
- Recall number
- D-1536-2022
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 11,802 1000-count bottles
- Termination date
- Jan 31, 2024
- Reason for recall
- Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-980-03
- Distribution pattern
- Product was distributed to major distributors/wholesalers nationwide.
- Recall initiation date
- Sep 13, 2022
- Initial firm notification
- Letter
- Center classification date
- Sep 15, 2022