Valsartan recalls: 29 FDA reports
Recalls involving Valsartan. What was wrong with each batch, and how the FDA graded the risk.
29Reports
0Class I
17Ongoing
2021-06-02Most 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.
Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC 59746-360-30 Manufactured by: Jubilant Generics Ltd.
D-0461-2021 · Class II · reported 2021-06-02 · Terminated
- Why it was recalled
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Product
- Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC 59746-360-30 Manufactured by: Jubilant Generics Ltd. Roorkee-247661, India
- Where it went
- FL, GA, SC
- How much
- 20 bottles
Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, N
D-1037-2019 · Class II · reported 2019-03-27 · Ongoing
- Why it was recalled
- GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- Product
- Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-570-30
- Where it went
- Product was distributed to major distribution chains throughout the United States.
- How much
- N/A
Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, N
D-1039-2019 · Class II · reported 2019-03-27 · Ongoing
- Why it was recalled
- GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- Product
- Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90
- Where it went
- Product was distributed to major distribution chains throughout the United States.
- How much
- N/A
Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton,
D-1035-2019 · Class II · reported 2019-03-27 · Ongoing
- Why it was recalled
- GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- Product
- Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90
- Where it went
- Product was distributed to major distribution chains throughout the United States.
- How much
- N/A
Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ
D-1038-2019 · Class II · reported 2019-03-27 · Ongoing
- Why it was recalled
- GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- Product
- Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90
- Where it went
- Product was distributed to major distribution chains throughout the United States.
- How much
- N/A
Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton,
D-0370-2019 · Class II · reported 2019-01-23 · Ongoing
- Why it was recalled
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
- Product
- Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-573-90.
- Where it went
- Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
- How much
- 20,604 bottles
Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceutica
D-0327-2019 · Class II · reported 2018-12-19 · Ongoing
- Why it was recalled
- GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- Product
- Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5815-77.
- Where it went
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- How much
- 129,754 HDPE bottles
Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceutical
D-0325-2019 · Class II · reported 2018-12-19 · Ongoing
- Why it was recalled
- GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- Product
- Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5813-77.
- Where it went
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- How much
- 119,761 HDPE bottles
Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceutica
D-0316-2019 · Class II · reported 2018-12-19 · Ongoing
- Why it was recalled
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
- Product
- Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5815-77.
- Where it went
- Product was distributed throughout the United States.
- How much
- 25,147 bottles
Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceutica
D-0326-2019 · Class II · reported 2018-12-19 · Ongoing
- Why it was recalled
- GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- Product
- Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5814-77.
- Where it went
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- How much
- 232,180 HDPE bottles
Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceutical
D-0315-2019 · Class II · reported 2018-12-19 · Ongoing
- Why it was recalled
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
- Product
- Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5807-93.
- Where it went
- Product was distributed throughout the United States.
- How much
- 63,213 bottles
Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceutica
D-0314-2019 · Class II · reported 2018-12-19 · Ongoing
- Why it was recalled
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
- Product
- Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5814-77.
- Where it went
- Product was distributed throughout the United States.
- How much
- 12,840 bottles
Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceutical
D-0324-2019 · Class II · reported 2018-12-19 · Ongoing
- Why it was recalled
- GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- Product
- Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5807-93.
- Where it went
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- How much
- 160,300 HDPE bottles
Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceutica
D-0313-2019 · Class II · reported 2018-12-19 · Ongoing
- Why it was recalled
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
- Product
- Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5813-77.
- Where it went
- Product was distributed throughout the United States.
- How much
- 24,709 bottles
Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 024766
D-1106-2018 · Class III · reported 2018-08-29 · Terminated
- Why it was recalled
- Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
- Product
- Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-363-90
- Where it went
- Product was distributed throughout the United States to wholesalers and retailers.
- How much
- 7,048 bottles
Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661
D-1103-2018 · Class III · reported 2018-08-29 · Terminated
- Why it was recalled
- Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
- Product
- Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-360-30
- Where it went
- Product was distributed throughout the United States to wholesalers and retailers.
- How much
- 10,577 bottles
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Ph
D-1116-2018 · Class II · reported 2018-08-29 · Completed
- Why it was recalled
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Product
- Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Pollepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-748-90 UPC 331722748902
- Where it went
- Nationwide
- How much
- 441,408 bottles
Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661
D-1104-2018 · Class III · reported 2018-08-29 · Terminated
- Why it was recalled
- Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
- Product
- Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-361-90
- Where it went
- Product was distributed throughout the United States to wholesalers and retailers.
- How much
- 9,552 bottles
Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 024766
D-1105-2018 · Class III · reported 2018-08-29 · Terminated
- Why it was recalled
- Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
- Product
- Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-362-90
- Where it went
- Product was distributed throughout the United States to wholesalers and retailers.
- How much
- 18,947 bottles
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Phar
D-1113-2018 · Class II · reported 2018-08-29 · Completed
- Why it was recalled
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Product
- Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Polepally Jadcherla Mahaboob Nagar - 509-301, India. NDC 31722-745-30 UPC 331722745307
- Where it went
- Nationwide
- How much
- 316,380 bottles
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: Camber Pha
D-1115-2018 · Class II · reported 2018-08-29 · Completed
- Why it was recalled
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Product
- Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Pollepally Jadcherla Mahabubnagar - 509-301, India. NDC 31722-747-90 UPC 331722747905
- Where it went
- Nationwide
- How much
- 441,408 bottles
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only Manufactured for: Camb
D-1114-2018 · Class II · reported 2018-08-29 · Completed
- Why it was recalled
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Product
- Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V. Polepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-746-90 UPC 331722746908
- Where it went
- Nationwide
- How much
- 394,896 bottles
Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA
D-1029-2018 · Class II · reported 2018-08-08 · Terminated
- Why it was recalled
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Product
- Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
- Where it went
- Product was distributed in HI, IN, and FL.
- How much
- 90 tablets
Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only Manufactured by: Zhejiang Huahai P
D-0971-2018 · Class II · reported 2018-08-01 · Ongoing
- Why it was recalled
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Product
- Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-370-09
- Where it went
- United States
- How much
- N/A
Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only Manufactured by: Zhejiang Huahai P
D-0969-2018 · Class II · reported 2018-08-01 · Ongoing
- Why it was recalled
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Product
- Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-368-09
- Where it went
- United States
- How much
- N/A
Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only Manufactured by: Zhejiang Huahai
D-0970-2018 · Class II · reported 2018-08-01 · Ongoing
- Why it was recalled
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Product
- Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-369-09
- Where it went
- United States
- How much
- N/A
Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only, Manufactured by: Zhejiang Huahai
D-0968-2018 · Class II · reported 2018-08-01 · Ongoing
- Why it was recalled
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Product
- Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-367-03
- Where it went
- United States
- How much
- N/A
Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, I
D-0876-2018 · Class III · reported 2018-06-13 · Terminated
- Why it was recalled
- Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
- Product
- Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90
- Where it went
- IN, MI, MS, NC, NJ, NY and OH
- How much
- 2,328 bottles (Lot VR417065A) and 2,352 bottles (Lot VR417066A)
Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co.
D-0209-2018 · Class II · reported 2018-01-17 · Terminated
- Why it was recalled
- Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
- Product
- Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare US, LLC, Cranbury, NJ 08512, USA; NDC 43547-369-09.
- Where it went
- Nationwide in the USA and Puerto Rico
- How much
- 21,987 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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