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.

1176–1200 of 1563

  • HighFDA (Drugs)·D-1442-2019·2019-06-26

    Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals is recalling Pramipexole Dihydrochloride Tablets 0.125 mg due to cross-contamination caused by a cleaning failure.

    Product
    Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1448-2019·2019-06-26

    Zydus Recalls Methylprednisolone Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals is recalling specific lots of Methylprednisolone tablets due to cross-contamination caused by cleaning failures.

    Product
    METHYLPREDNISOLONE — METHYLPREDNISOLONE (METHYLPREDNISOLONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1450-2019·2019-06-26

    Zydus Recalls Methylprednisolone Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals is recalling specific lots of Methylprednisolone tablets due to cross-contamination caused by cleaning failures.

    Product
    METHYLPREDNISOLONE — METHYLPREDNISOLONE (METHYLPREDNISOLONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1445-2019·2019-06-26

    Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross Contamination

    Zydus Pharmaceuticals USA Inc is recalling Pramipexole Dihydrochloride Tablets 0.25 mg due to cross contamination caused by a cleaning failure.

    Product
    Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1449-2019·2019-06-26

    Zydus Recalls Methylprednisolone Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals is recalling Methylprednisolone tablets due to cross-contamination caused by cleaning failures. The affected lots are distributed nationwide.

    Product
    METHYLPREDNISOLONE — METHYLPREDNISOLONE (METHYLPREDNISOLONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1444-2019·2019-06-26

    Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals is recalling Pramipexole Dihydrochloride Tablets 0.25 mg due to cross-contamination caused by cleaning failures.

    Product
    Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-197-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1447-2019·2019-06-26

    Zydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination

    Zydus Pharmaceuticals is recalling Pramipexole Dihydrochloride Tablets 1 mg due to cross-contamination caused by a cleaning failure.

    Product
    Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-199-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1310-2019·2019-06-05

    Inopak Recalls Antibacterial Foaming Hand Wash for CGMP Deviations

    Inopak Ltd is recalling specific batches of Antibacterial Foaming Hand Wash because they were not produced under current good manufacturing practices.

    Product
    ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X, packaged in a) 18 oz bottles, 12/18 oz bottles per case, 5063-432-02; b) 1 gallon bottles, 4/1 gallon bottles per case, 5063-420-03; c) Options Systems Antibacterial Foaming H
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1319-2019·2019-06-05

    Inopak Recalls Unison Hand Cleaner for Manufacturing Practice Violations

    Inopak Ltd is recalling Unison Hand Care Products due to production not meeting current good manufacturing practices.

    Product
    Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Triclosan, #4302, with exclusive Bajan fragrance, packaged in 800 ML (27 FL OZ) pouch containers, 12-800 ml containers/12-27 FL. OZ. container pouches per case, National Chemical Laboratories, Inc., 401 N
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1316-2019·2019-06-05

    Inopak Recalls Mild Health Care Antibacterial Hand Soap for CGMP Deviations

    Inopak Ltd is recalling Mild Health Care Antibacterial Hand Soap because it was not produced under current good manufacturing practices.

    Product
    Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 ml Disc Pump pouches, 8 x 1000 ml Disc Pump pouches per case, 5013-L1000, b) 2000 ml. Disc Pump pouches, 4 x 2000 ml Disc Pump pouches per case, 5013-XL2000, c) 800 ml Universal Valve pouches, 12 x 800 ml
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1311-2019·2019-06-05

    Inopak Recalls AQUACIL Hand Sanitizer Due to Manufacturing Deviations

    Inopak Ltd is recalling specific batches of AQUACIL instant foaming hand sanitizer because they were not produced under current good manufacturing practices.

    Product
    AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1% (w/w), packaged in a) 18 FL OZ (532 mL) bottles, 12/18OZ bottles per case, Product Code BIO-5075-432-02; b) 1000 ML pouches, 6/1000 ML pouches per case, Product Code BIO575-OS1000, Biocentris
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1314-2019·2019-06-05

    Inopak Recalls INOFOAM Food Handling Wash for CGMP Deviations

    Inopak Ltd is recalling INOFOAM Foaming E-2 Food Handling Wash because it was not produced under current good manufacturing practices.

    Product
    INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11), 6/1000 ML pouches per case (NDC 058575-110-80), 5064-FL1000, Inopak, LTD.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1315-2019·2019-06-05

    Inopak Recalls Antibacterial Hand Soap Due to Manufacturing Deviations

    Inopak Ltd is recalling specific batches of Healthcare 2000 antibacterial hand soap because they were not produced under current good manufacturing practices.

    Product
    Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin Cleanser (Chlorhexidine Gluconate), 4 x (1 gallon containers), Reorder/REF #JSCG; Manufactured for Crosstex International, Inc.; b) MEDI-WASH CHG Anti-Microbial Hand Wash with C
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1317-2019·2019-06-05

    Inopak Recalls Sani-Guard-SF Foam Hand Sanitizer Due to Manufacturing Deviations

    Inopak Ltd is recalling Sani-Guard-SF Waterless Foam Hand Sanitizer because it was not produced under current good manufacturing practices.

    Product
    Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per case, 5068-FL1000, b) 1000 ml cartridge pouch, 6/1000 ml .8ml Option Cartridge pouches per case, 5068-OS1000, Inopak LTD
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1312-2019·2019-06-05

    Inopak Recalls Hand Sanitizer Due to Manufacturing Practice Deviations

    Inopak Ltd is recalling DermaGel and SaniTyze hand sanitizers because they were not produced under current good manufacturing practices.

    Product
    Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel Instant Waterless Hand Sanitizing Gel with Moisturizers, with Aloe Vera & Vitamin E, packaged in a) 1000 ml Disc Pump pouches (NDC 58575-340), 8 x 1000 ml Disc Pump pouches per case, Product Code 5025-L
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1313-2019·2019-06-05

    Inopak Recalls Inoderm Antiseptic Hand Soap Due to Manufacturing Deviations

    Inopak Ltd is recalling Inoderm Antiseptic Hand Soap because it was not produced under current good manufacturing practices.

    Product
    INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) PCMX, 800ml/27fl.oz.pouches (NDC 058575-110), 12 x 800 Bag-N-Box pouches per case (NDC 058575-110-80), 5014-404-NB; INOPAK, 24 Executive PKWY, Ringwood, NJ 07456.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1318-2019·2019-06-05

    Inopak Antibacterial Hand Soap Recalled for CGMP Deviations

    Inopak Ltd is recalling specific batches of Antibacterial Hand Soap because they were not produced under current good manufacturing practices.

    Product
    Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soap with moisturizers, a) 1000 ml pouches, 10/1000 ML. Large Valve pouches per case, 5031-404-LN, b) 1000 ml pouches, 8/1000 ML. Disc Pumps pouches per case, 5031-L1000, c) 800 ML Universal Valve pouches,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1283-2019·2019-05-29

    Losartan Potassium Tablets Recalled Due to Impurity Presence

    Golden State Medical Supply Inc. is recalling Losartan Potassium Tablets 25 mg because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 25 mg 90 count bottle NDC 60429-316-90 Rx only GSMS Incorporated
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-1290-2019·2019-05-29

    Heritage Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Heritage Pharmaceuticals is recalling Losartan Potassium Tablets 100 mg because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceut
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1263-2019·2019-05-08

    Losartan Potassium Tablets Recalled Due to Trace Nitrosamine Impurity

    Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets 50 mg due to trace amounts of the impurity NMBA found in the active ingredient.

    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 6
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1270-2019·2019-05-08

    Losartan Potassium/HCTZ Tablets Recalled for Nitrosamine Impurity

    RemedyRepack is recalling Losartan Potassium/HCTZ tablets because FDA testing found a nitrosamine impurity above acceptable levels.

    Product
    Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, Inc. Indiana, PA, 15701-3570, NDC 70518-1560-00.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1119-2019·2019-04-17

    Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Losartan Potassium / Hydrochlorothiazide Tablets because FDA labs found an impurity above acceptable levels.

    Product
    Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, a) 30-count (NDC: 13668-118-30), b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: To
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1083-2019·2019-04-17

    Losartan Potassium Tablets Recalled Due to Nitrosamine Impurity

    Pharma Pac is recalling Losartan Potassium 100 mg tablets because traces of a nitrosamine impurity were found in the active ingredient.

    Product
    Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with "H" on one side and "145" on the other side.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1055-2019·2019-03-27

    Rising Pharmaceuticals Recalls Valsartan Tablets Due to NDEA Impurity

    Rising Pharmaceuticals is recalling Valsartan Tablets 320 mg due to CGMP deviations and the detection of a trace amount of the impurity N-nitrosodiethylamine (NDEA).

    Product
    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
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1052-2019·2019-03-27

    Rising Pharmaceuticals Recalls Valsartan Tablets Due to NDEA Impurity

    Rising Pharmaceuticals is recalling Valsartan Tablets 40 mg due to CGMP deviations and the detection of a trace amount of the impurity NDEA.

    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
    Category
    Drug
    Distribution
    0 states