Recall archive / FDA drug enforcement

Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-... — FDA record D-0843-2022

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 Mar 31, 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: Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC# 68180-216-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA
Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Classification: Class II
Recalling firm: Lupin Pharmaceuticals Inc.
Quantity: 2,361,924 bottles
Agency-reported status: Terminated
Source record identifier: D-0843-2022

Open the official record

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

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lot # H001878 6/30/2022 68180-216-06 H002178 7/31/2022 68180-216-06 H002626 9/30/2022 68180-216-06 H102149 9/30/2023 68180-216-06 H001600 5/31/2022 68180-216-09 H001601 5/1/2022 68180-216-09 H001625 5/31/2022 68180-216-09 H001626 5/31/2022 68180-216-09 H001794 6/30/2022 68180-216-09 H001795 6/30/2022 68180-216-09 H001796 6/30/2022 68180-216-09 H001797 6/30/2022 68180-216-09 H001879 6/30/2022 68180-216-09 H001880 6/30/2022 68180-216-09 H001881 6/30/2022 68180-216-09 H001942 6/30/2022 68180-216-09 H001943 6/30/2022 68180-216-09 H001944 6/30/2022 68180-216-09 H001945 6/30/2022 68180-216-09 H001946 6/30/2022 68180-216-09 H002179 7/31/2022 68180-216-09 H002180 7/31/2022 68180-216-09 H002181 8/31/2022 68180-216-09 H002182 8/31/2022 68180-216-09 H002183 8/31/2022 68180-216-09 H002237 8/31/2022 68180-216-09 H002238 8/31/2022 68180-216-09 H002239 8/31/2022 68180-216-09 H002240 8/31/2022 68180-216-09 H002241 8/31/2022 68180-216-09 H002627 9/30/2022 68180-216-09 H002628 9/30/2022 68180-216-09 H002629 9/30/2022 68180-216-09 H002630 9/30/2022 68180-216-09 H002631 9/30/2022 68180-216-09 H002979 11/30/2022 68180-216-09 H002980 11/30/2022 68180-216-09 H002981 11/30/2022 68180-216-09 H002982 11/30/2022 68180-216-09 H002983 11/30/2022 68180-216-09 H100112 12/31/2022 68180-216-09 H100113 12/31/2022 68180-216-09 H100114 12/31/2022 68180-216-09 H100115 12/31/2022 68180-216-09 H100116 12/31/2022 68180-216-09 H100156 12/31/2022 68180-216-09 H100157 12/31/2022 68180-216-09 H100622 2/28/2023 68180-216-09 H100623 2/28/2023 68180-216-09 H100624 2/28/2023 68180-216-09 H100625 2/28/2023 68180-216-09 H100626 2/28/2023 68180-216-09 H100627 2/28/2023 68180-216-09 H100628 2/28/2023 68180-216-09 H100629 2/28/2023 68180-216-09 H100939 4/30/2023 68180-216-09 H100940 4/30/2023 68180-216-09 H100941 4/30/2023 68180-216-09 H100942 4/30/2023 68180-216-09 H100943 4/30/2023 68180-216-09 H101094 5/31/2023 68180-216-09 H101095 5/31/2023 68180-216-09 H101096 5/31/2023 68180-216-09 H101097 5/31/2023 68180-216-09 H101098 5/31/2023 68180-216-09 H101151 5/31/2023 68180-216-09 H101152 5/31/2023 68180-216-09 H101290 5/31/2023 68180-216-09 H101291 5/31/2023 68180-216-09 H101292 5/31/2023 68180-216-09 H101293 5/31/2023 68180-216-09 H101323 5/31/2023 68180-216-09 H101324 5/31/2023 68180-216-09 H101823 7/31/2023 68180-216-09 H101824 7/31/2023 68180-216-09 H101825 7/31/2023 68180-216-09 H101853 8/31/2023 68180-216-09 H101854 8/31/2023 68180-216-09 H101855 8/31/2023 68180-216-09 H101856 8/31/2023 68180-216-09 H102127 9/30/2023 68180-216-09 H102128 9/30/2023 68180-216-09 H102129 9/30/2023 68180-216-09 H102130 9/30/2023 68180-216-09 H102150 9/30/2023 68180-216-09 H102151 9/30/2023 68180-216-09 H102152 9/30/2023 68180-216-09 H102153 9/30/2023 68180-216-09 H102154 9/30/2023 68180-216-09 H102155 9/30/2023 68180-216-09 H102201 9/30/2023 68180-216-09 H102223 9/30/2023 68180-216-09 H102268 9/30/2023 68180-216-09 H102269 9/30/2023 68180-216-09 H102270 9/30/2023 68180-216-09 H102271 9/30/2023 68180-216-09

Label field

Details supplied by the agency

Lot, code or applicability

Lot # H001878 6/30/2022 68180-216-06 H002178 7/31/2022 68180-216-06 H002626 9/30/2022 68180-216-06 H102149 9/30/2023 68180-216-06 H001600 5/31/2022 68180-216-09 H001601 5/1/2022 68180-216-09 H001625 5/31/2022 68180-216-09 H001626 5/31/2022 68180-216-09 H001794 6/30/2022 68180-216-09 H001795 6/30/2022 68180-216-09 H001796 6/30/2022 68180-216-09 H001797 6/30/2022 68180-216-09 H001879 6/30/2022 68180-216-09 H001880 6/30/2022 68180-216-09 H001881 6/30/2022 68180-216-09 H001942 6/30/2022 68180-216-09 H001943 6/30/2022 68180-216-09 H001944 6/30/2022 68180-216-09 H001945 6/30/2022 68180-216-09 H001946 6/30/2022 68180-216-09 H002179 7/31/2022 68180-216-09 H002180 7/31/2022 68180-216-09 H002181 8/31/2022 68180-216-09 H002182 8/31/2022 68180-216-09 H002183 8/31/2022 68180-216-09 H002237 8/31/2022 68180-216-09 H002238 8/31/2022 68180-216-09 H002239 8/31/2022 68180-216-09 H002240 8/31/2022 68180-216-09 H002241 8/31/2022 68180-216-09 H002627 9/30/2022 68180-216-09 H002628 9/30/2022 68180-216-09 H002629 9/30/2022 68180-216-09 H002630 9/30/2022 68180-216-09 H002631 9/30/2022 68180-216-09 H002979 11/30/2022 68180-216-09 H002980 11/30/2022 68180-216-09 H002981 11/30/2022 68180-216-09 H002982 11/30/2022 68180-216-09 H002983 11/30/2022 68180-216-09 H100112 12/31/2022 68180-216-09 H100113 12/31/2022 68180-216-09 H100114 12/31/2022 68180-216-09 H100115 12/31/2022 68180-216-09 H100116 12/31/2022 68180-216-09 H100156 12/31/2022 68180-216-09 H100157 12/31/2022 68180-216-09 H100622 2/28/2023 68180-216-09 H100623 2/28/2023 68180-216-09 H100624 2/28/2023 68180-216-09 H100625 2/28/2023 68180-216-09 H100626 2/28/2023 68180-216-09 H100627 2/28/2023 68180-216-09 H100628 2/28/2023 68180-216-09 H100629 2/28/2023 68180-216-09 H100939 4/30/2023 68180-216-09 H100940 4/30/2023 68180-216-09 H100941 4/30/2023 68180-216-09 H100942 4/30/2023 68180-216-09 H100943 4/30/2023 68180-216-09 H101094 5/31/2023 68180-216-09 H101095 5/31/2023 68180-216-09 H101096 5/31/2023 68180-216-09 H101097 5/31/2023 68180-216-09 H101098 5/31/2023 68180-216-09 H101151 5/31/2023 68180-216-09 H101152 5/31/2023 68180-216-09 H101290 5/31/2023 68180-216-09 H101291 5/31/2023 68180-216-09 H101292 5/31/2023 68180-216-09 H101293 5/31/2023 68180-216-09 H101323 5/31/2023 68180-216-09 H101324 5/31/2023 68180-216-09 H101823 7/31/2023 68180-216-09 H101824 7/31/2023 68180-216-09 H101825 7/31/2023 68180-216-09 H101853 8/31/2023 68180-216-09 H101854 8/31/2023 68180-216-09 H101855 8/31/2023 68180-216-09 H101856 8/31/2023 68180-216-09 H102127 9/30/2023 68180-216-09 H102128 9/30/2023 68180-216-09 H102129 9/30/2023 68180-216-09 H102130 9/30/2023 68180-216-09 H102150 9/30/2023 68180-216-09 H102151 9/30/2023 68180-216-09 H102152 9/30/2023 68180-216-09 H102153 9/30/2023 68180-216-09 H102154 9/30/2023 68180-216-09 H102155 9/30/2023 68180-216-09 H102201 9/30/2023 68180-216-09 H102223 9/30/2023 68180-216-09 H102268 9/30/2023 68180-216-09 H102269 9/30/2023 68180-216-09 H102270 9/30/2023 68180-216-09 H102271 9/30/2023 68180-216-09

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

Distribution

Product was distributed 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: May 11, 2022
Recall initiation date: Mar 31, 2022
Center classification date: May 3, 2022
Termination date: May 22, 2023

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.