The Recall Desk
HighFDA (Drugs)·D-1536-2022·Announced 2022-09-21

Lisinopril Tablets Recalled for Embedded Metal Contamination

Lupin Pharmaceuticals is recalling Lisinopril 10 mg tablets due to discovery of a metal piece embedded in one tablet. Affected lot Q201182 was distributed nationwide to wholesalers.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II drug recall with a physical contaminant (metal piece) embedded in a tablet, posing a risk of harm if ingested. No illnesses or injuries have been reported to date, but the presence of a foreign object in medication represents a legitimate safety hazard.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling Lisinopril Tablets USP, 10 mg, in 1000-count bottles due to discovery of foreign material (a metal piece) embedded in one tablet.

A metal piece was found embedded within a single tablet in the affected lot, which poses a potential safety risk to consumers if the contaminated tablet is taken.

The recall affects 11,802 bottles of 1000-count Lisinopril tablets (lot # Q201182, expiration date March 2024). The affected product was distributed to major pharmaceutical distributors and wholesalers nationwide. NDC 68180-980-03.

Consumers taking Lisinopril from this lot should contact their pharmacist or healthcare provider. Do not consume tablets from this lot. Return the product to the pharmacy where it was obtained, or contact Lupin Pharmaceuticals for instructions on returning the product.

The recalled product

Product
LISINOPRIL (LISINOPRIL)
Brand
LISINOPRIL
Manufacturer
Lupin Pharmaceuticals Inc.
Hazard
  • metal-contamination
  • choking

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # Q201182
  • exp. date March 2024

UPCs (3)

  • 0368180513018
  • 0368180512028
  • 0368180513032

Distribution

Distributed nationwide across the United States.

Same brand · LISINOPRIL