Losartan Potassium recalls: 20 FDA reports
Recalls involving Losartan Potassium. What was wrong with each batch, and how the FDA graded the risk.
20Reports
0Class I
3Ongoing
2023-07-12Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed
D-0895-2023 · Class II · reported 2023-07-12 · Terminated
- Why it was recalled
- Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
- Product
- Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram- 603 110, Tamilnadu, India, NDC 64380-933-08
- Where it went
- Nationwide in the USA.
- How much
- 2,700 HDPE Bottles
Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuti
D-1162-2022 · Class II · reported 2022-07-06 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Product
- Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-164-90 UPC 3 72789 16490 8
- Where it went
- Nationwide
- How much
- 687 bottles
Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed and Packaged By: PD-Rx Pharmaceu
D-1163-2022 · Class II · reported 2022-07-06 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Product
- Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-165-90 UPC 3 72789 16590 5
- Where it went
- Nationwide
- How much
- 1320 bottles
Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuti
D-1161-2022 · Class II · reported 2022-07-06 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Product
- Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-163-90 UPC 3 72789 16390 1
- Where it went
- Nationwide
- How much
- 1441 bottles
Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot
D-0973-2022 · Class II · reported 2022-06-08 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Product
- Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-934-05 1000 film coated tablets NDC 64380-934-08
- Where it went
- Nationwide
- How much
- 381456 bottles
Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot
D-0974-2022 · Class II · reported 2022-06-08 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Product
- Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-935-05 1000 film coated tablets NDC 64380-935-08
- Where it went
- Nationwide
- How much
- 96966 bottles
Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Plot
D-0972-2022 · Class II · reported 2022-06-08 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Product
- Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-933-05 1000 film coated tablets NDC 64380-933-08
- Where it went
- Nationwide
- How much
- 200407 bottles
Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 3
D-0833-2022 · Class II · reported 2022-05-11 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Product
- Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
- Where it went
- Product was distributed nationwide.
- How much
- 3216/30 count bottles; 47,904/90 count bottles; 4269/1000 count bottles = 8,676,840 tablets
Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC #
D-0832-2022 · Class II · reported 2022-05-11 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Product
- Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
- Where it went
- Product was distributed nationwide.
- How much
- 12,408/90 count bottles; 1670/1000 count bottles =2,786,720 tablets
Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC#
D-0840-2022 · Class II · reported 2022-05-11 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Product
- Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.
- Where it went
- Product was distributed nationwide
- How much
- 1,247,067 bottles
Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC #
D-0834-2022 · Class II · reported 2022-05-11 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Product
- Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
- Where it went
- Product was distributed nationwide.
- How much
- 3288/30 count bottles; 23,904/90 count bottles; 3364/1000 count bottles = 5,614,000 tablets
Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 6
D-0839-2022 · Class II · reported 2022-05-11 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Product
- Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.
- Where it went
- Product was distributed nationwide
- How much
- 1,466,150 bottles
Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 6
D-0838-2022 · Class II · reported 2022-05-11 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Product
- Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.
- Where it went
- Product was distributed nationwide
- How much
- 657,336 bottles
Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a)
D-0341-2021 · Class II · reported 2021-05-05 · Terminated
- Why it was recalled
- CGMP deviation: Product found to contain trace amounts of NMBA
- Product
- Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 60 Tablets NDC: 43063-854-60; b) 90 Tablets NDC: 43063-0854-90
- Where it went
- AK, AZ, CA, CO, FL, KY, MA, MI, MN, NC, OH, OR, WI, WY
- How much
- 576 bottles
Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsb
D-1458-2019 · Class II · reported 2019-07-17 · Terminated
- Why it was recalled
- CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- Product
- Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-44
- Where it went
- Nationwide
- How much
- 4277 bottles (4,277,000 tablets)
Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro
D-1457-2019 · Class II · reported 2019-07-17 · Terminated
- Why it was recalled
- CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- Product
- Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-10
- Where it went
- Nationwide
- How much
- 47520 bottles (4,276,800 tablets)
Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30), b) 90 count (NDC 31722-701-90)
D-1042-2019 · Class II · reported 2019-03-27 · Ongoing
- Why it was recalled
- CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
- Product
- Losartan Potassium Tablets USP, 50 mg, Rx only, a) 30 count (NDC 31722-701-30), b) 90 count (NDC 31722-701-90), c) 1000 count (NDC 31722-701-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India
- Where it went
- Nationwide
- How much
- 69712 bottles
Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-30), b) 90 count (NDC 31722-702-30
D-1043-2019 · Class II · reported 2019-03-27 · Ongoing
- Why it was recalled
- CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
- Product
- Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-30), b) 90 count (NDC 31722-702-30), c) 1000 count (NDC 31722-702-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India
- Where it went
- Nationwide
- How much
- 683,641 bottles
Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), b) 500 count (NDC 31722-700-05
D-1041-2019 · Class II · reported 2019-03-27 · Ongoing
- Why it was recalled
- CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
- Product
- Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), b) 500 count (NDC 31722-700-05) and c) 1000 count (NDC 31722-700-05) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India
- Where it went
- Nationwide
- How much
- 351,732 bottles
LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufactured by: Micro Labs Limited, Goa-
D-0253-2015 · Class II · reported 2014-11-26 · Terminated
- Why it was recalled
- Failed Content Uniformity Specifications; Dry mix failed blend uniformity.
- Product
- LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufactured by: Micro Labs Limited, Goa-403 722, INDIA. Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540. NDC 42571-110-10
- Where it went
- U.S. Including: New York
- How much
- 144 bottles
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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