Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
3 Class I (most serious) drug recalls reported in the last 30 days.
1,094 recalls
-
Class II Ongoing
Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 41167-0310-1 41167-0310-2 41167-0310-3 41167-0310-4 41167-0310-6 41167-0310-7 41167-0310-8
Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
Lots, distribution and details
- Product
- Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 41167-0310-1 41167-0310-2 41167-0310-3 41167-0310-4 41167-0310-6 41167-0310-7 41167-0310-8
- Lots / codes
- all lots
- Distribution
- Nationwide
- Quantity
- —
- Recall started
- October 22, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0536-2020
-
Class II Ongoing
Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's 41167-0300-0, 41167-0300-1, 41167-0300-3, 41167-0300-5, 41167-0300-6, 41167-0300-7, 41167-030…
Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
Lots, distribution and details
- Product
- Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's 41167-0300-0, 41167-0300-1, 41167-0300-3, 41167-0300-5, 41167-0300-6, 41167-0300-7, 41167-0300-8
- Lots / codes
- all lots
- Distribution
- Nationwide
- Quantity
- —
- Recall started
- October 22, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0535-2020
-
Class II Ongoing
Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0120-06, 0597-0120-08, 0597-0120-09, 0597-0120-24, 0597-0120-…
Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
Lots, distribution and details
- Product
- Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0120-06, 0597-0120-08, 0597-0120-09, 0597-0120-24, 0597-0120-38, 0597-0120-50, 0597-0120-76, 0597-0120-78, 0597-0120-80, 0597-0120-82, 0597-0120-87.
- Lots / codes
- all lots
- Distribution
- Nationwide
- Quantity
- —
- Recall started
- October 22, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0534-2020
-
Class II Ongoing
Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-05
Reason: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Lots, distribution and details
- Lots / codes
- RA1518002-B Jul 2020 RA1518003-A Jul 2020 RA1518004-A Aug 2020 RA1518005-A Aug 2020 RA1518007-A Sep 2020 RA1518008-A Sep 2020 RA1518009-A Sep 2020 RA1518010-A Oct 2020 RA1518011-A Nov 2020 RA1518012-A Nov 2020 RA1518013-A Nov 2020 RA1518014-A Nov 2020 RA1518015-A Nov 2020 RA1519003-B May 2021 RA1519004-A May 2021
- Distribution
- nationwide
- Quantity
- 26,736 bottles
- Recall started
- November 6, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0530-2020
-
Class II Ongoing
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74
Reason: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Lots, distribution and details
- Product
- Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74
- Lots / codes
- UI1519001-A UI1519002-A UI1519003-A UI1519004-A
- Distribution
- nationwide
- Quantity
- 19320 bottles
- Recall started
- November 6, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0529-2020
-
Class II Ongoing
Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-145-30
Reason: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Lots, distribution and details
- Product
- Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-145-30
- Lots / codes
- RA3018001-A Jul 2020 RA3018002-A Jul-2020 RA3018003-A Jul 2020 RA3018004-A Aug 2020 RA3018005-A Aug 2020 RA3018006-A Aug 2020 RA3018007-A Sep 2020 RA3018008-A Sep 2020 RA3018009-A Sep 2020 RA3018010-A Oct 2020 RA3019001-A Jan 2021 RA3019002-A Jan 2021 RA3019003-A May 2021
- Distribution
- nationwide
- Quantity
- 134,160 bottles
- Recall started
- November 6, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0528-2020
-
Class II Ongoing
Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60
Reason: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Lots, distribution and details
- Product
- Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60
- Lots / codes
- RA1518001-A Jul 2020 RA1518002-A Jul 2020 RA1518005-B Aug 2020 RA1518006-A Aug 2020 RA1519003-A May 2021
- Distribution
- nationwide
- Quantity
- 45,456 bottles
- Recall started
- November 6, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0527-2020
-
Class II Ongoing
DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79
Reason: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Lots, distribution and details
- Product
- DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79
- Lots / codes
- Lot # NBSB19001DA3; Exp FEB 2021
- Distribution
- nationwide
- Quantity
- 69,696 bottles
- Recall started
- November 6, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0526-2020
-
Class III Ongoing
Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79
Reason: CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
Lots, distribution and details
- Product
- Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79
- Lots / codes
- Lot #: NBSB19001DA3, Exp. date 02/2021
- Distribution
- Nationwide within the United States
- Quantity
- 69696 bottles
- Recall started
- September 23, 2019 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0166-2020
-
Class II Ongoing
Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged…
Reason: CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
Lots, distribution and details
- Product
- Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202, Manufactured for: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-494-54
- Lots / codes
- Lot 181598; 02/2021
- Distribution
- TN, AZ
- Quantity
- 60,012 bottles
- Recall started
- April 24, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1263-2019
-
Class II Ongoing
Valsartan Tablets 320 mg USP, 90 tablet bottles, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 — NDC 52343-125-90
Reason: CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Lots, distribution and details
- Lots / codes
- 473180007A, exp. date 03/31/2020 473180008A, exp. date 03/31/2020 473180011A, exp. date 04/30/2020 473180020B1, exp. date 07/31/2020 473170019B, exp. date 10/31/2019
- Distribution
- Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.
- Quantity
- 42,016 bottles
- Recall started
- March 7, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1055-2019
-
Class II Ongoing
Valsartan Tablets 160 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 —- NDC 52343-124-90
Reason: CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Lots, distribution and details
- Lots / codes
- 472180005B, exp. date 02/29/2020 472180011A, exp. date 04/30/2020 472180012A, exp. date 04/30/2020
- Distribution
- Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.
- Quantity
- 35,281 bottles
- Recall started
- March 7, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1054-2019
-
Class II Ongoing
Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 — NDC 52343-123-90
Reason: CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Lots, distribution and details
- Product
- Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 — NDC 52343-123-90
- Lots / codes
- 471170019A, exp. date 10/31/2019 471180006A, exp. date 03/31/2020 471180007A, exp. date 03/31/2020 471180016A, exp. date 05/31/2020
- Distribution
- Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.
- Quantity
- 37,410 bottles
- Recall started
- March 7, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1053-2019
-
Class II Ongoing
Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ, Manufactured by: Aurolife Pharma LLC, Dayton, NJ —- NDC 52343-122-30
Reason: CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Lots, distribution and details
- Product
- Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ, Manufactured by: Aurolife Pharma LLC, Dayton, NJ —- NDC 52343-122-30
- Lots / codes
- 470170038A, exp. date 10/31/2019 470180010A, exp. date 02/29/2019 470180012A, exp. date 03/31/2020
- Distribution
- Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.
- Quantity
- 30,530 bottles
- Recall started
- March 7, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1052-2019
-
Class II Ongoing
Losartan Potassium Tablets, USP, 100 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutica…
Reason: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Lots, distribution and details
- Product
- Losartan Potassium Tablets, USP, 100 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045. NDC 68645-579-54
- Lots / codes
- 180886, Nov-19; 180887, 180888, 180905, Dec-19; 181123, Sep-2019; 181124, Oct-2019, 181125, Aug-19, 181351, Nov-19, 181352, Dec-19, 181551, Nov-19, 181628, 181629, 181727, 181728, Jun-20; 181890, Mar-20; 181891, 181897, Jun-20; 182114, Mar-20; 182119, 182120, Jun-20
- Distribution
- Wal-Mart distribution centers in AR, CA, GA, IN and MD
- Quantity
- 2,497,856 bottles
- Recall started
- March 1, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1050-2019
-
Class II Ongoing
Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical…
Reason: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Lots, distribution and details
- Product
- Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045. NDC 68645-578-54
- Lots / codes
- Lots: 180921, exp Sep-19, 180922, exp Oct-19, 180923, 180924, 181118, exp Nov-19, 181119, exp Oct-19, 181407, exp Nov-19, 181408, exp Dec-19, 181573, 181725, 181726, exp Feb-20, 181948, exp Mar-20, 181960, exp Feb-20, 182385, 182386, 182387, exp Mar-20
- Distribution
- Wal-Mart distribution centers in AR, CA, GA, IN and MD
- Quantity
- 2,851,284 bottles
- Recall started
- March 1, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1049-2019
-
Class II Ongoing
Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical…
Reason: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Lots, distribution and details
- Product
- Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-577-54
- Lots / codes
- Lots: 180952, exp Oct-19, 180953, exp Dec-19, 181086, exp Sep-19, 181572, exp Jan-20
- Distribution
- Wal-Mart distribution centers in AR, CA, GA, IN and MD
- Quantity
- 456,732 bottles
- Recall started
- March 1, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1048-2019
-
Class II Ongoing
Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ — NDC 65862-572-90
Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Lots, distribution and details
- Lots / codes
- Lot Numbers: 472180001A, 472180002A, 472180003A, 472180004A, exp. date Jan 2020; 472180007A, 472180008A, 472180009A, 472180010A, exp. date Mar 2020; 472180013A, 472180014A, exp. date Apr 2020
- Distribution
- Product was distributed to major distribution chains throughout the United States.
- Quantity
- N/A
- Recall started
- December 31, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1039-2019
-
Class II Ongoing
Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ — NDC 65862-571-90
Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Lots, distribution and details
- Lots / codes
- Lot Numbers: 471170015A, exp. date Sep 2019; 471180004A, 471180005A, exp. date Feb 2019
- Distribution
- Product was distributed to major distribution chains throughout the United States.
- Quantity
- N/A
- Recall started
- December 31, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1038-2019
-
Class II Ongoing
Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ — NDC 65862-570-30
Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Lots, distribution and details
- Product
- Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ — NDC 65862-570-30
- Lots / codes
- Lot Numbers: 470180008A, exp. date Feb 2020; 470180014A, 470180016A, exp. date Mar 2020; 470180032A, exp. date May 2020
- Distribution
- Product was distributed to major distribution chains throughout the United States.
- Quantity
- N/A
- Recall started
- December 31, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1037-2019
-
Class II Ongoing
Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ — NDC 65862-573-90
Reason: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Lots, distribution and details
- Product
- Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ — NDC 65862-573-90
- Lots / codes
- Lot Numbers: 473180004A, 473180005A, exp. date Feb 2020; 473180006A, exp. date Mar 2020; 473180016A, 473180017A, exp. date May 2020; 473170019A, exp. date Oct 2019
- Distribution
- Product was distributed to major distribution chains throughout the United States.
- Quantity
- N/A
- Recall started
- December 31, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1035-2019
-
Class II Ongoing
Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany,…
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots, distribution and details
- Product
- Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054.
- Lots / codes
- NDC 0591-2170-19 Lot Numbers: 1208002A, 1247282M, 1263944M NDC 0591-2170-05 Lot Numbers: 1208000M, 1208001M, 1240425A
- Distribution
- Product was distributed throughout the United States, including Hawaii and Puerto Rico
- Quantity
- 13,555 90-count bottles; 2,892 500-count bottles
- Recall started
- July 16, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0989-2018
-
Class II Ongoing
Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bottle (NDC 0591-2169-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany…
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots, distribution and details
- Product
- Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bottle (NDC 0591-2169-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
- Lots / codes
- NDC 0591-2169-19 Lot Numbers: 1177880A, 1220831A, 1263941A NDC 0591-2169-10 1175922M, 1220826M, 1236294M, 1240427M, 1270616A
- Distribution
- Product was distributed throughout the United States, including Hawaii and Puerto Rico
- Quantity
- 15,347 90-count bottles, 8,378 1000-count bottles
- Recall started
- July 16, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0988-2018
-
Class II Ongoing
Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count bottle (NDC 0591-2168-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany,…
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots, distribution and details
- Product
- Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count bottle (NDC 0591-2168-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
- Lots / codes
- Lot Numbers: NDC 0591-2168-19 1175947M, 1175948M, 1177115A, 1219361A, 1240434M, 1250704M NDC 0591-2168-10 1177114A, 1219360M, 1250706A
- Distribution
- Product was distributed throughout the United States, including Hawaii and Puerto Rico
- Quantity
- 30,793 90-count bottles, 1,158 1000-count bottles
- Recall started
- July 16, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0987-2018
-
Class II Ongoing
Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bottle (NDC 0591-2167-19), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, N…
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Lots, distribution and details
- Product
- Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bottle (NDC 0591-2167-19), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
- Lots / codes
- Lot Numbers: NDC 0591-2167-30 1196936A, 1238463A, 1270617A NDC 0591-2167-19 1196934M, 1238462M, 1268429A
- Distribution
- Product was distributed throughout the United States, including Hawaii and Puerto Rico
- Quantity
- 8,046 30-count bottles, 20,841 90-count bottles
- Recall started
- July 16, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0986-2018
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update November 4, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.