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.

226–250 of 1563

  • HighFDA (Drugs)·D-0552-2025·2025-08-13

    Duloxetine 60 mg capsules exceed the safety assessment limit for nitrosamine

    Duloxetine Delayed-Release Capsules USP 60 mg distributed by Breckenridge are being recalled because N-nitroso-duloxetine was present above the safety assessment limit. 1,829 bottles affected.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0573-2025·2025-08-13

    Recombinate antihemophilic factor vials exposed to temperatures outside labeled storage

    Recombinate [Antihemophilic Factor (Recombinant)] 5 mL vials are being recalled because of CGMP deviations: the product was exposed to temperatures outside its labeled storage requirements. 3 units affected.

    Product
    RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0571-2025·2025-08-13

    Xolair auto-injectors exposed to temperatures outside labeled storage requirements

    Xolair (omalizumab injection) 150 mg/mL auto-injectors are being recalled because of CGMP deviations: the product was exposed to temperatures outside its labeled storage requirements. 6 units affected.

    Product
    XOLAIR — XOLAIR (OMALIZUMAB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0545-2025·2025-08-06

    Bicillin L-A 2.4 million unit vials recalled after particulates found

    Bicillin L-A (penicillin G benzathine injectable suspension) 2,400,000 units per 4 mL is being recalled because of CGMP deviations, with particulates identified during visual inspection. 19,279 vials affected.

    Product
    BICILLIN L-A — BICILLIN L-A (PENICILLIN G BENZATHINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0544-2025·2025-08-06

    Bicillin L-A penicillin vials recalled after particulates found during visual inspection

    Bicillin L-A (penicillin G benzathine injectable suspension) 1,200,000 units per 2 mL is being recalled because of CGMP deviations, with particulates identified during visual inspection. 50,855 vials affected.

    Product
    BICILLIN L-A — BICILLIN L-A (PENICILLIN G BENZATHINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0547-2025·2025-08-06

    Sucralfate tablets recalled because bankruptcy left the quality program unmonitored

    Sucralfate Tablets USP 1 gram from Nostrum Laboratories are being recalled across all lots within expiry because the firm cannot monitor its quality program after filing for Chapter 11. 60,608 bottles affected.

    Product
    Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0534-2025·2025-07-23

    Rizatriptan 10 mg tablets exceed the acceptable intake limit for nitrosamine

    Rizatriptan Benzoate Tablets USP 10 mg are being recalled after detection of N-nitroso-dimethyl-rizatriptan above the FDA recommended acceptable intake limit.

    Product
    RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0533-2025·2025-07-23

    Rizatriptan 5 mg tablets exceed the acceptable intake limit for nitrosamine

    Rizatriptan Benzoate Tablets USP 5 mg are being recalled after detection of N-nitroso-dimethyl-rizatriptan above the FDA recommended acceptable intake limit.

    Product
    RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0550-2025·2025-07-23

    Power Stick roll-on antiperspirant recalled over manufacturing practice deviations

    Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant is being recalled because of CGMP deviations. 23,467 cases are affected.

    Product
    Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant, 1.8 oz./ 53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-040-00 UPC Code 815195018224
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0548-2025·2025-07-23

    Power Stick for her roll-on antiperspirant recalled over manufacturing deviations

    Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent is being recalled because of CGMP deviations. 21,265 cases are affected.

    Product
    Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-038-00, UPC Code 815195019313
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0549-2025·2025-07-23

    Power Stick Spring Fresh roll-on antiperspirant recalled over manufacturing deviations

    Beauty & Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant Spring Fresh is being recalled because of CGMP deviations. 22,482 cases are affected.

    Product
    Beauty & Skincare Power Stick original nourishing invisible protection roll-on Antiperspirant/Deodorant Spring Fresh, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-039-00, UPC Code 815195018194
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0513-2025·2025-07-16

    Erin's Faces mineral sunscreen recalled over manufacturing practice deviations

    Erin's Faces Mineral SPF 32 sunscreen is being recalled because of cGMP deviations. 54 tubes are affected.

    Product
    Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Zinc Oxide, 3 FL OZ/ 85 mL per bottle, Made in USA for Erin's Faces, Millburn, NO 07041. NDC: 73369-1401-1
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0515-2025·2025-07-16

    In Your Face tinted mineral sunscreen recalled over manufacturing practice deviations

    In Your Face Mineral Tint SPF 31 tinted sunscreen is being recalled because of cGMP deviations. 76 bottles are affected.

    Product
    In Your Face Mineral Tint SPF 31, Zinc Oxide 25%, Tinted Sunscreen Broad Spectrum UVA & UVB chemical free, Organic Ingredients, Biodegradable & Baby Safe, 50 mL - 1.7 fl oz per bottle, Manufactured for IN YOUR FACE Skin Care, Belleair Bluffs, FL, Made in USA, NDC: 73369-1601-1
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0514-2025·2025-07-16

    GreenScreen zinc oxide sunscreen recalled over manufacturing practice deviations

    GreenScreen organic zinc oxide sunscreen SPF 32 is being recalled because of cGMP deviations. 174 tubes are affected.

    Product
    GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Sunscreen, Organic Ingredients, Fragrance Free, Biodegradable, Chemical Free, Non-Nano, Baby Safe, Original, SPF 32, Totally Green personal care, Zinc Oxide USP 25%, 3.4 FL OZ/115 G Tube, NDC: 73369-0001-1
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0512-2025·2025-07-16

    B Natural Organics mineral sunscreens recalled over manufacturing practice deviations

    B Natural Organics Organic Sunscreen SPF 30, in tinted and tint free formulas, is being recalled because of cGMP deviations. 204 tubes are affected.

    Product
    B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Zinc Oxide, a) Nude Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1002-2; b) Tint Free Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1001-2; c)
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0456-2025·2025-06-11

    Fluoxetine Tablets 20 mg Recalled for N-Nitroso Impurity

    Torrent Pharma Inc. is recalling Fluoxetine Tablets, USP, 20 mg in a 28-count carton due to the presence of N-Nitroso Fluoxetine exceeding the interim acceptable intake limit.

    Product
    FLUOXETINE — FLUOXETINE (FLUOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0455-2025·2025-06-11

    Fluoxetine Tablets USP 20 mg Recalled for N-Nitroso Contamination

    Torrent Pharma Inc. is recalling Fluoxetine Tablets USP 20 mg due to the presence of N-Nitroso Fluoxetine exceeding the interim acceptable intake limit. The affected lot is distributed nationwide.

    Product
    FLUOXETINE — FLUOXETINE (FLUOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0450-2025·2025-06-04

    Carvedilol Tablets 12.5 mg Recalled for Impurity Above Limit

    Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 12.5 mg due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit, resulting from current Good Manufacturing Practice (CGMP) deviations.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0451-2025·2025-06-04

    Carvedilol Tablets 25 mg Recalled Due to Impurity Above Acceptable Limit

    Glenmark Pharmaceuticals is recalling Carvedilol Tablets USP 25 mg nationwide due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit, resulting from CGMP deviations.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0449-2025·2025-06-04

    Carvedilol Tablets 6.25 mg Recalled for N-Nitroso Impurity

    Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 6.25 mg due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit. The recall affects 100-count and 500-count bottles distributed nationwide.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide