Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, ... — FDA record D-1536-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 13, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
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
Reason
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Classification
Class II
Recalling firm
Lupin Pharmaceuticals Inc.
Quantity
11,802 1000-count bottles
Agency-reported status
Terminated
Source record identifier
D-1536-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityLot # Q201182, exp. date March 2024

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Product was distributed to major distributors/wholesalers nationwide.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Sep 21, 2022
Recall initiation date
Sep 13, 2022
Center classification date
Sep 15, 2022
Termination date
Jan 31, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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