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.

1326–1350 of 1563

  • ModerateFDA (Drugs)·D-0421-2018·2018-02-21

    BonaDur For Men Lidocaine Spray Recalled for Manufacturing Deviations

    Webrx dba RxPalace.com is recalling BonaDur For Men lidocaine spray because it was not manufactured according to current good manufacturing practices.

    Product
    BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. (7.4 mL) spray bottles, Manufactured by WebRx Pharmacy Palace, Sarasota, FL 34232; NDC 70582-999-74
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0594-2018·2018-02-14

    Hetero Labs Recalls Aripiprazole Tablets Due to CGMP Deviations

    Hetero Labs is recalling 3,000 bottles of Aripiprazole 10 mg tablets because the active ingredient did not meet all intended specifications.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0341-2018·2018-02-07

    PD-Rx Recalls Ibuprofen 200 mg Tablets Due to Manufacturing Deviations

    PD-Rx Pharmaceuticals is voluntarily recalling 7,174 bottles of Ibuprofen 200 mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC 55289-673-24; b) 30 tablets NDC 55289-673-30; c) 50 tablets NDC 55289-673-50; d) 60 tablets NDC 55289-673-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0211-2018·2018-01-17

    Akorn Recalls Gabapentin Oral Solution Due to Unapproved Manufacturer

    Akorn Inc is recalling 4,885 bottles of Gabapentin Oral Solution because the product was released with an unapproved active ingredient manufacturer.

    Product
    Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701. NDC: 50383-311-47
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0083-2018·2017-11-29

    United Therapeutics Recalls Tyvaso Inhalation Devices Due to Manufacturing Deviations

    United Therapeutics is voluntarily recalling 12 Tyvaso Inhalation System Starter Kits due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation System Starter Kit Model# TD-100/A, Rx Only, Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709, NDC# 6630220601
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0008-2018·2017-10-18

    United Pharmacy Recalls Compounded Glutamine Injection Vials Due to CGMP Deviations

    United Pharmacy is recalling 268 vials of compounded Glutamine, Arginine, and Carnitine injection due to CGMP deviations and the absence of glutamine.

    Product
    Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded, 13951 N. Haverhill Rd Ste. 120-121 West Palm Beach, FL 33417
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0001-2018·2017-10-11

    Pfizer Recalls Deferoxamine Mesylate Injection Due to CGMP Deviations

    Pfizer is recalling 32,276 vials of Deferoxamine Mesylate for injection due to a failure to control impurities causing color change at the API stage.

    Product
    Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. Intravenous, Intramuscular, Subcutaneous Use, Rx Only, Hospira, Inc., Lake Forest IL USA, NDC 0406-2336-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1174-2017·2017-09-27

    Medisca Recalls Aminocaproic Acid API Due to CGMP Labeling Deviations

    Medisca, Inc. is recalling Aminocaproic Acid API lots because the product was manufactured for industrial use but labeled for pharmacy compounding.

    Product
    Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredient, packaged in a) 100 g jar (NDC 38779-0989-05, b) 1 kg jar (NDC 38779-0989-09), and 25 kg drum (NDC 38779-0989-07), Rx only, Packed by Medisca Inc., Plattsburgh, NY 12901, CAS: 60-32-1. 38779-0989-05;
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1127-2017·2017-09-13

    Lupin Recalls Famotidine Oral Suspension Due to Manufacturing Deviations

    Lupin Pharmaceuticals is recalling 12,888 bottles of Famotidine for Oral Suspension due to CGMP deviations. The FDA classified this voluntary recall as Class III.

    Product
    FAMOTIDINE — FAMOTIDINE (FAMOTIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1040-2017·2017-08-09

    Axia Pharmaceutical Recalls Compounded Testosterone Cypionate and Progesterone Vials

    Axia Pharmaceutical is recalling 120 vials of compounded Testosterone Cypionate and Progesterone due to CGMP deviations. The product was distributed to one customer in California.

    Product
    Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los Angeles, CA 90025
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0938-2017·2017-07-12

    Xttrium Recalls Chlorhexidine Gluconate Oral Rinse Due to CGMP Deviations

    Xttrium Laboratories is voluntarily recalling 36,720 bottles of Chlorhexidine Gluconate 0.12% Oral Rinse due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    CHLORHEXIDINE GLUCONATE — CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE GLUCONATE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0905-2017·2017-06-21

    Safecor Health Recalls Metronidazole Tablets Due to CGMP Deviations

    Safecor Health LLC is voluntarily recalling 1,933 bottles of Metronidazole 500mg tablets due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 5011133402
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0902-2017·2017-06-21

    Safecor Health Recalls Calcium Carbonate and Vitamin D3 Tablets

    Safecor Health is recalling 25 bottles of Calcium Carbonate and Vitamin D3 tablets due to CGMP deviations. The product was distributed in Massachusetts and New York.

    Product
    Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904323392.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0900-2017·2017-06-21

    Safecor Health Recalls Acetaminophen Tablets Due to Manufacturing Deviations

    Safecor Health is recalling 66 bottles of Acetaminophen 325mg tablets due to Current Good Manufacturing Practice (CGMP) deviations. The affected lot was distributed in Massachusetts and New York.

    Product
    Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904198280.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0903-2017·2017-06-21

    Safecor Recalls Acyclovir 400mg Tablets Due to Manufacturing Deviations

    Safecor Health is recalling 601 bottles of Acyclovir 400mg tablets distributed in Massachusetts and New York due to CGMP deviations.

    Product
    Acyclovir 400mg Tablet, 15-count bottles, Rx only, Packaged by Safecor Health, LLC. Woburn, MA 01801, NDC 0093894305
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0901-2017·2017-06-21

    Safecor Health Recalls Atorvastatin Calcium 40mg Tablets Due to CGMP Deviations

    Safecor Health is voluntarily recalling 119 bottles of Atorvastatin Calcium 40mg tablets in Massachusetts and New York due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Atorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor Health Woburn, MA 01801, NDC 60505258009
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0882-2017·2017-06-14

    Spectrum Chemical Recalls Levonorgestrel API Due to CGMP Deviations

    Spectrum Laboratory Products is recalling levonorgestrel active pharmaceutical ingredient due to manufacturing deviations found by the FDA.

    Product
    Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg container, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code L1229.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0894-2017·2017-06-14

    Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

    Qualgen is recalling Estradiol 12.5 mg pellets due to CGMP deviations and a lack of quality assurance. The recall covers 4,883 pellets distributed nationwide.

    Product
    Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-012-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0890-2017·2017-06-14

    Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

    Qualgen is recalling Estradiol 22 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 1,666 pellets distributed nationwide.

    Product
    Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-022-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0893-2017·2017-06-14

    Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

    Qualgen is recalling Estradiol 15 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 6,227 units distributed nationwide.

    Product
    Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles. Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-015-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0895-2017·2017-06-14

    Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

    Qualgen is recalling Estradiol 10 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 5,260 pellets distributed nationwide.

    Product
    Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only , For Subcutaneous Use Only Rx Only Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-010-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0896-2017·2017-06-14

    Qualgen Estradiol Pellets Recalled for Quality Assurance Deviations

    Qualgen is recalling Estradiol 6 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 4,815 pellets distributed nationwide.

    Product
    Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by; Qualgen 14844 Bristol Park Blvd. Edmond, OK 73013 NDC: 69761-006-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0892-2017·2017-06-14

    Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

    Qualgen is recalling Estradiol 18 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 6,361 pellets distributed nationwide.

    Product
    Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-018-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0891-2017·2017-06-14

    Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

    Qualgen is recalling Estradiol 20 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 4,468 pellets distributed nationwide.

    Product
    Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-020-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0889-2017·2017-06-14

    Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

    Qualgen is recalling Estradiol 25 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 1,153 pellets distributed nationwide.

    Product
    Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only. Rx Only ,Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-025-01,
    Category
    Drug
    Distribution
    Distributed nationwide