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
289
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 289 (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.

351–375 of 1563

  • ModerateFDA (Drugs)·D-0197-2024·2024-01-03

    Prescription drug SPIRIVA recalled for temperature storage deviation

    SPIRIVA (tiotropium bromide) inhalation powder batch 104440 is being recalled nationwide due to exposure to temperatures outside the product's labeled storage conditions during manufacturing.

    Product
    SPIRIVA — SPIRIVA (TIOTROPIUM BROMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0172-2024·2024-01-03

    Chlorthalidone Tablets Recalled for Temperature Storage Deviations

    Cardinal Healthcare is recalling Chlorthalidone Tablets, 25mg (Batch 2107329UM) distributed nationwide because products were exposed to temperatures outside the labeled storage conditions.

    Product
    CHLORTHALIDONE — CHLORTHALIDONE (CHLORTHALIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0174-2024·2024-01-03

    Colgate Total SF Toothpaste recalled for improper storage temperature exposure

    Colgate Total SF Toothpaste (Batch 1293US561C, 4.8 oz, Clean Mint) distributed nationwide is being recalled due to CGMP deviations where products were exposed to temperatures outside labeled storage conditions.

    Product
    Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%, Clean Mint, Dist. by: COLGATE-PALMOLIVE CO., New York, NY 10022 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0082-2024·2023-11-08

    Iodine Solution Recalled for Manufacturing Compliance Deviations

    Safecor Health recalls Strong Iodine Solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The prescription product was distributed in multiple lots across the U.S.

    Product
    STRONG IODINE SOLUTION — STRONG IODINE SOLUTION (STRONG IODINE SOLUTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0033-2024·2023-10-11

    Dr. Berne's MSM Drops Recalled Due to Manufacturing Practice Deviations

    Dr. Berne's MSM DROPS is being recalled due to manufacturing practice deviations. The recall involves 6,060 bottles distributed nationwide and internationally.

    Product
    Dr. Berne's MSM DROPS 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected], UPC 00854582001036
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0034-2024·2023-10-11

    Dr. Berne's MSM MIST 15% Topical Spray Recalled for Manufacturing Deviations

    Dr. Berne's Whole Health Products has voluntarily recalled Dr. Berne's MSM MIST 15% Solution (30 mL bottles) due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The recall affects 795 bottles distributed nationwide and internationally.

    Product
    Dr. Berne's MSM MIST 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected].
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1101-2023·2023-08-30

    FDA Recalls AstrinGyn Surgical Hemostatic Due to Manufacturing Practice Deviations

    Ecometics is recalling 92,967 vials of AstrinGyn (Ferric Subsulfate) Aqueous due to manufacturing practice violations. The product was not manufactured under current good manufacturing practices (CGMP).

    Product
    AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1089-2023·2023-08-30

    Drug manufacturer recalls Protex hand sanitizer due to manufacturing quality deviations

    Parker Laboratories is recalling Protex Foaming Hand Sanitizer due to manufacturing quality control deviations. The voluntary recall affects products distributed nationwide and internationally.

    Product
    Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2 fl oz/60 mL Pump bottles (NDC 30775-040-02) and b)18 fl. oz./550 ml Pump Bottles (NDC 30775-040-18), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1091-2023·2023-08-30

    Helix Tri-Active Therapy Cream Recalled for Manufacturing Quality Deviations

    Parker Laboratories is voluntarily recalling Helix Tri-Active Therapy Cream due to manufacturing quality control deviations. The recall affects products with lot numbers A1221010 and A1221011, expiring December 9, 2023, distributed in the United States, Singapore, Korea, and Hong Kong.

    Product
    Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%), packaged in a) 3 fl. oz. roll-on (NDC 30775-052-03) and b) 4 fl. oz. tube (NDC 30775-052-04) Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0942-2023·2023-08-02

    Safe Tussin DM Cough Suppressant Recalled for Manufacturing Deviation

    Kramer Laboratories is recalling Safe Tussin DM Cough + Chest Congestion due to a manufacturing deviation involving non-food grade lubricant in the mixing vessel. Affected lots 8753, 8753A, and 8659 were distributed nationwide.

    Product
    Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), 2020 Kramer Laboratories, Inc. Bridgewater, NJ 08807
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0897-2023·2023-07-19

    Sunmark and Generic Eye Drops Recalled for Manufacturing Deficiency

    K.C. Pharmaceuticals is recalling 341,568 bottles of Sunmark and generic tetrahydrozoline eye drops due to manufacturing practice deficiencies. The recall affects multiple brands distributed nationwide.

    Product
    SUNMARK EYE DROPS ORIGINAL FORMULA — SUNMARK EYE DROPS ORIGINAL FORMULA (TETRAHYDROZOLINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0898-2023·2023-07-19

    Eye drops Equate and private-label brands recalled for manufacturing documentation deficiency

    K.C. Pharmaceuticals is recalling 397,430 bottles of Equate and private-label dry eye relief drops nationwide due to Current Good Manufacturing Practice deficiencies related to fill line documentation.

    Product
    EQUATE EYE DROPS DRY EYE RELIEF — EQUATE EYE DROPS DRY EYE RELIEF (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0888-2023·2023-07-05

    FDA Recalls StellaLife VEGA Oral Care Spray for Manufacturing Practice Violations

    The FDA is recalling StellaLife VEGA Oral Care Spray due to current Good Manufacturing Practice (cGMP) deviations. The product was distributed nationwide.

    Product
    StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-101-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0880-2023·2023-07-05

    Drug recall: Kanjo homeopathic pain relief cream with arnica due to manufacturing deviations

    Homeocare Laboratories recalls Kanjo Homeopathic Pain Relief Cream due to manufacturing process deviations. The recall affects 921 bottles distributed nationwide.

    Product
    Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For: Acutens, Inc., Sheridan, WY NDC 80551-201-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0883-2023·2023-07-05

    Homeopathic diarrhea remedy recalled due to manufacturing control deviations

    Homeocare Laboratories is recalling Babelyn Diarrhea Drops due to manufacturing control (cGMP) deviations. The voluntary recall affects 5,957 bottles distributed nationwide.

    Product
    Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-035-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0866-2023·2023-06-14

    Levsin injection recalled for manufacturing quality program discontinuation

    Viatris Inc. is recalling Levsin injection (hyoscyamine sulfate, 0.5 mg/ml) due to discontinuation of the quality assurance program that verifies product identity, strength, quality, and purity. The recall affects 2,736 boxes distributed to 10 distributors.

    Product
    Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Distributed by: Meda pharmaceuticals Inc. (a Viatris company) Somerset New Jersey 00873-4120, NDC #0037-9001-05
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0869-2023·2023-06-14

    Buprenorphine Sublingual Tablets Recalled for Manufacturing Quality Deviations

    Sun Pharmaceutical recalls 12,336 bottles of Buprenorphine 8 mg sublingual tablets (Lot DND1515A) due to Good Manufacturing Practice deviations identified during manufacturing.

    Product
    BUPRENORPHINE — BUPRENORPHINE (BUPRENORPHINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0814-2023·2023-06-07

    Akorn Lactulose Solution Recalled Due to Incomplete Stability Studies

    Akorn, Inc. is recalling all lots of Lactulose Solution USP (Oral), 10g/15mL, distributed nationwide in the USA and Puerto Rico, due to the manufacturer's inability to complete required stability studies following company closure.

    Product
    Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL bottles, c) 473 mL bottles, and d) 946 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0811-2023·2023-06-07

    Akorn Hydromorphone Hydrochloride Injection Recalled Due to CGMP Deviations

    Akorn, Inc. is recalling all lots of Hydromorphone Hydrochloride Injection due to CGMP deviations. The firm went out of business and could not complete required stability testing.

    Product
    Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL ampules, b) 5 mL ampules, c) 50 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0854-2023·2023-06-07

    Valproic Acid Oral Solution Recalled for Manufacturing Compliance Deviation

    Akorn, Inc. is recalling all lots of Valproic Acid Oral Solution, USP (250mg/5mL) nationwide. The recall was issued because the firm ceased operations and could not complete required stability studies as mandated by manufacturing regulations.

    Product
    Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0786-2023·2023-06-07

    FDA Recalls All Lots Akorn Artificial Tears Ointment Nationwide

    Akorn is recalling all lots of Artificial Tears Ointment nationwide due to manufacturing compliance deviations. The company went out of business and was unable to complete required stability studies.

    Product
    Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0853-2023·2023-06-07

    Akorn Tropicamide Ophthalmic Solution Recalled for Manufacturing Quality Deviations

    Akorn recalls all lots of Tropicamide Ophthalmic Solution 0.5% (15 mL bottles) nationwide due to CGMP deviations. The firm was unable to complete required stability studies after ceasing operations.

    Product
    Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0828-2023·2023-06-07

    Midazolam Injection Recalled Due to Manufacturing Compliance and Stability Study Issues

    Akorn, Inc. is recalling all lots of Midazolam Injection USP 2mg/2mL nationwide because the manufacturer went out of business and cannot complete required stability studies mandated by Current Good Manufacturing Practice regulations.

    Product
    Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use Only, 2mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0798-2023·2023-06-07

    FDA Recalls DetomiSed Drug Due to Incomplete Stability Testing

    FDA is recalling all lots of DetomiSed (detomidine hydrochloride), a prescription-only drug, nationwide. Akorn Inc., the manufacturer, went out of business and could no longer conduct stability studies.

    Product
    DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0834-2023·2023-06-07

    Oxcarbazepine Oral Suspension Recalled Due to Manufacturing and Stability Deviations

    Akorn Inc. is recalling all lots of Oxcarbazepine Oral Suspension 300 mg/5 mL due to manufacturing practice deviations. The firm went out of business and could not complete required stability studies.

    Product
    Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide