The Recall Desk

Hazard

Cgmp Deviation recalls

1,563 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,563
Critical
1
Severe
288
Most recent
2026-09-09

Of the 1,563 cgmp deviation recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 288 (18%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all cgmp deviation recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1201–1225 of 1563

  • SevereFDA (Drugs)·D-1053-2019·2019-03-27

    Rising Pharmaceuticals Recalls Valsartan Tablets Due to NDEA Impurity

    Rising Pharmaceuticals is recalling Valsartan Tablets 80 mg due to CGMP deviations and the detection of a trace amount of the impurity NDEA.

    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
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1054-2019·2019-03-27

    Rising Pharmaceuticals Recalls Valsartan Tablets Due to NDEA Impurity

    Rising Pharmaceuticals is recalling Valsartan Tablets 160 mg due to CGMP deviations and the detection of a trace amount of the impurity NDEA.

    Product
    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
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-1002-2019·2019-03-20

    Roberts Home Medical Recalls Refrigerated Liquid Oxygen Cylinders Due to CGMP Deviations

    Roberts Home Medical LLC is voluntarily recalling 9 refrigerated liquid oxygen reservoirs due to Current Good Manufacturing Practice (CGMP) deviations. The product was distributed in Maryland, Virginia, and the District of Columbia.

    Product
    Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b) Roberts Home Medical, Inc. Germantown, MD. 20875
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0502-2019·2019-02-27

    Torrent Pharma Recalls Losartan Potassium Tablets Due to NDEA Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium Tablets, 50 mg, because FDA testing found the impurity N-nitrosodimethylamine (NDEA) above acceptable levels.

    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0513-2019·2019-02-27

    Lupin Recalls Lovastatin Tablets Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling Lovastatin 40 mg tablets because the drug substance used was out of specification for impurity results.

    Product
    LOVASTATIN — LOVASTATIN (LOVASTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0486-2019·2019-02-20

    LGM Pharma Recalls Cidofovir Dihydrate Due to CGMP Deviations

    LGM Pharma LLC is recalling Cidofovir Dihydrate because the API manufacturer is on FDA Import Alert for CGMP deviations.

    Product
    CIDOFOVIR DIHYDRATE, (Non-Sterile, For Manufacturing Use), 10g, Rx only, ALP PHARM BEIJING CO., LTD, 12-2-620, Jia 69, Fushi Rd., Haidian, Beijing 100049, China. Batch Number JD-BP-37-20150801
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0409-2019·2019-02-06

    Prinston Recalls Irbesartan Tablets Due to NDEA Impurity

    Prinston Pharmaceutical Inc. is recalling Irbesartan 300 mg tablets because FDA testing found N-nitrosodimethylamine (NDEA) levels above the interim acceptable daily intake.

    Product
    IRBESARTAN — IRBESARTAN (IRBESARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0413-2019·2019-02-06

    Prinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Prinston Pharmaceutical Inc is recalling Irbesartan and Hydrochlorothiazide tablets because FDA labs found the impurity NDEA above acceptable levels.

    Product
    IRBESARTAN AND HYDROCHLOROTHIAZIDE — IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0412-2019·2019-02-06

    Prinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Prinston Pharmaceutical Inc. is recalling Irbesartan and Hydrochlorothiazide tablets because FDA testing found the impurity NDEA above acceptable limits.

    Product
    IRBESARTAN AND HYDROCHLOROTHIAZIDE — IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0423-2019·2019-02-06

    Lupin Recalls Cephalexin Oral Suspension Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling 14,400 bottles of Cephalexin for Oral Suspension due to CGMP deviations and the presence of extraneous material in sucrose excipients.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0363-2019·2019-01-23

    Aurobindo Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

    Aurobindo Pharma USA Inc. is recalling Amlodipine and Valsartan tablets because FDA labs found N-nitrosodimethylamine (NDEA) above acceptable levels.

    Product
    AMLODIPINE AND VALSARTAN — AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0368-2019·2019-01-23

    Aurobindo Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because FDA testing found the impurity NDEA above acceptable levels.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0375-2019·2019-01-16

    Lupin Recalls Cefdinir Oral Suspension Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension because product complaints indicated the reconstituted suspension was observed to be thick.

    Product
    CEFDINIR — CEFDINIR (CEFDINIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0376-2019·2019-01-16

    Lupin Recalls Cefdinir Oral Suspension Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension due to product complaints indicating the reconstituted suspension was observed to be thick.

    Product
    CEFDINIR — CEFDINIR (CEFDINIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0317-2019·2018-12-19

    Mylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Mylan Pharmaceuticals is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because FDA labs confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0300-2019·2018-12-19

    Westminster Irbesartan Tablets Recalled Due to NDEA Impurity

    Westminster Pharmaceuticals is recalling specific lots of Irbesartan tablets because FDA testing found traces of the NDEA impurity.

    Product
    Westminster Irbesartan Tablets, USP 75 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-119-01; b) 90 count bottle NDC 69367-119-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0270-2019·2018-11-28

    Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity

    Sciegen Pharmaceuticals is recalling GSMS Irbesartan Tablets, 75 mg, because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).

    Product
    GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Marketed by: GSMS Incorporated Camarillo, CA 93012 USA, NDC 60429-640-90.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0221-2019·2018-11-14

    S.C. Johnson Recalls Alcohol-Free Foaming Hand Sanitizer Due to CGMP Deviations

    S.C. Johnson Professional is recalling 258 cases of Alcohol Free Foaming Hand Sanitizer because the product was released to market prior to microbiological testing.

    Product
    Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Safe-T-Fresh Inc., USA, 2530 Xenium Lane North, Minneapolis, MN 55441.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0220-2019·2018-11-14

    S.C. Johnson Recalls Deb Stoko Refresh AntiBac Foam Due to CGMP Deviations

    S.C. Johnson Professional is recalling 869 cases of Deb Stoko Refresh AntiBac Foam because the product was released to market before microbiological testing was completed.

    Product
    deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Made in the USA, Deb USA, Inc., Charlotte, NC 28217, NDC 11084-010-27.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0042-2019·2018-10-24

    Meijer Sterile Saline Nasal Mist Recalled for Quality Control Issues

    Product Quest Manufacturing LLC is recalling Meijer Sterile Saline Nasal Mist cans due to manufacturing deviations that could impact product quality.

    Product
    Meijer, Sterile Saline Nasal Mist (0.9% Sodium Chloride Solution), 4.25 OZ (120 g) can, Dist. By Meijer Distribution, Inc., 2929 Walker Ave. NW, Grand Rapids, MI 49544, UPC 7 13733 27615 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0045-2019·2018-10-24

    FDA Recalls Premier Value Nasal Decongestant Due to Manufacturing Deviations

    Product Quest Manufacturing LLC is recalling Premier Value Nasal Decongestant due to CGMP deviations that could impact product quality.

    Product
    Premier Value, Nasal Decongestant, No Drip Nasal Spray (oxymetazoline HCl) Nasal Solution, 12 Hour Pump Mist, Maximum Strength, 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-308-03, UPC 8 40986 01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0031-2019·2018-10-24

    CVS Health Saline Nasal Spray Recalled for Manufacturing Deviations

    Product Quest Manufacturing LLC is recalling 552 bottles of CVS Health Saline Nasal Spray due to CGMP deviations that could impact product quality.

    Product
    CVS Health, Saline Nasal Spray, Nasal Moisturizing Spray, Contains: Sodium Chloride 0.65%, Benzyl Alcohol & Benzalkonium Chloride as Preservatives, 1.5 FL OZ (44 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 40814 8 Product #8914
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0023-2019·2018-10-24

    Humco Recalls Thyroid Powder Due to Inconsistent Active Ingredient Levels

    Humco Holding Group, Inc. is recalling Thyroid, USP (Porcine) powder because it has inconsistent levels of levothyroxine and liothyronine.

    Product
    Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only 100 grams NDC 0395-8077-62 Packaged by: Humco Texarkana, TX 75501 USA
    Category
    Drug
    Distribution
    Distributed nationwide