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.
0 Class I (most serious) drug recalls reported in the last 30 days.
59 recalls
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Class II Ongoing
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…
Reason: CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Lots, distribution and details
- 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
- Lots / codes
- a) LOP17026B, LOP17050, LOP1705, LOP17052, LOP17053, Exp. Sep-19; LOP17061, Exp. Oct-19; LOP18035, LOP18036, Exp. Dec-19; b) LOP17026, Exp. Sep-19; c) LOP17006, Exp. May-19, LOP17025, Exp. Sep-19, LOP17068, Exp, Oct-19, LOP18037, LOP18038, LOP18039, Exp. Dec-19, LOP18057, Exp. Jan-20
- Distribution
- Nationwide
- Quantity
- 351,732 bottles
- Recall started
- February 28, 2019 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1041-2019
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Class II Ongoing
LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count bottle (NDC: 13668-116-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 7…
Reason: 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.
Lots, distribution and details
- Product
- LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count bottle (NDC: 13668-116-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
- Lots / codes
- Count, lots, expiry: [90-count bottle] Lot BP02C008, exp 03/2019; [1000-count bottle] Lots BEF7D006, exp 03/2020
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 18,780 bottles
- Recall started
- December 20, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0505-2019
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Class II Ongoing
LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count bottle (NDC: 13668-117-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382…
Reason: 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.
Lots, distribution and details
- Product
- LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count bottle (NDC: 13668-117-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
- Lots / codes
- Count, lots, expiry: [90-count bottle] Lot BX35C020, exp 05/2019, Lot BX35C049, exp 08/2019; [1000-count bottle] Lots BX35C022, BX35C023, exp 05/2019
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 18,852 bottles
- Recall started
- December 20, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0504-2019
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Class II Ongoing
LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
Reason: 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.
Lots, distribution and details
- Lots / codes
- Count, lots, expiry: [90-count bottle] Lot 4O49C013, exp 09/2019
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 43,416 bottles
- Recall started
- December 20, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0503-2019
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Class II Ongoing
LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-count bottle (NDC: 13668-409-90), c) 1000-count bottle (NDC: 13668-409-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Ind…
Reason: 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.
Lots, distribution and details
- Product
- LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-count bottle (NDC: 13668-409-90), c) 1000-count bottle (NDC: 13668-409-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
- Lots / codes
- Count, lots, expiry: [30-count bottle] Lot 4L67C035, exp 10/2019; [90-count bottle] Lot 4L67C035, 4L67C036 exp 10/2019; [1000-count bottle] Lot 4O50C005, exp 11/2019
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 65,832 bottles
- Recall started
- December 20, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0502-2019
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Class II Ongoing
LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668-115-90), c) 1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 7…
Reason: 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.
Lots, distribution and details
- Product
- LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668-115-90), c) 1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
- Lots / codes
- Count, lots, expiry: [30-count bottle] Lot BO31C016, exp 04/2019; [90-count bottle] Lot BO31C016, exp 04/2019; [1000-count bottle] Lots 4DK3C004, 4DK3C005, exp 04/2019; Lots 4DU3C040, exp 10/2019; Lots 4DU3E049, 4DU3E050, exp 05/2021
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 83,016 bottles
- Recall started
- December 20, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0501-2019
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Class II Ongoing
Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufactured by: Lek Pharmaceuticals d.d. SI-1526 Ljubljana,Sovenia for Sandoz Inc., Princet…
Reason: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Lots, distribution and details
- Product
- Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufactured by: Lek Pharmaceuticals d.d. SI-1526 Ljubljana,Sovenia for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5207-10.
- Lots / codes
- Lot #: JB8912; Exp. 06/2020
- Distribution
- OH, PR
- Quantity
- 170 HDPE bottles
- Recall started
- November 1, 2018 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0359-2019
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Class I Ongoing
Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar – 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 088…
Reason: Labeling: Label Mix-Up – One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
Lots, distribution and details
- Product
- Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar – 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30
- Lots / codes
- Lot #: MON17384, Exp 12/19
- Distribution
- U.S.A. Nationwide
- Quantity
- 98016 bottles
- Recall started
- August 15, 2018 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0081-2019
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Class II Ongoing
Potassium Phosphate Injection, compounded by Olympia Pharmacy, Orlando, FL
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Lots, distribution and details
- Lots / codes
- K5019 Exp 9/30/13
- Distribution
- Nationwide and PR
- Quantity
- 1
- Recall started
- May 29, 2013 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-774-2013
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 October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.