The Recall Desk

Hazard

Cgmp Deviation recalls

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

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.

76–100 of 547

  • HighFDA (Drugs)·D-0408-2025·2025-05-14

    Polyvinyl Alcohol Eye Drops Recalled for Sterility and Manufacturing Issues

    BRS Analytical Services is recalling Polyvinyl Alcohol ophthalmic solution due to cGMP deviations and lack of sterility assurance. Consumers should stop using affected lots immediately.

    Product
    POLYVINYL ALCOHOL — POLYVINYL ALCOHOL (POLYVINYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0411-2025·2025-05-14

    Clindamycin HCl Capsules 300 mg Recalled Due to Manufacturing Practice Deviations

    RemedyRePack Inc. is recalling Clindamycin HCl Capsule 300 mg due to manufacturing practice deviations in a facility shared with Ezetimibe tablets. Affected lots B3698036-033125 and B3688703-032625 were distributed in PA, VA, and FL.

    Product
    Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-0405-2025·2025-05-14

    Eye Lubricant Gel Recalled for Manufacturing Control Failures

    AvKARE is recalling carboxymethylcellulose sodium ophthalmic gel due to cGMP deviations and failure to assure sterility. Affected lots were distributed nationwide.

    Product
    Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0410-2025·2025-05-14

    Temper Tamer Homeopathic Oral Spray Recalled for Manufacturing Practice Deviations

    Siddha Flower Essences is recalling Temper Tamer homeopathic oral spray (Lot S22-26424D) due to manufacturing practice deviations. The product was distributed nationwide.

    Product
    temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by: Siddha Flower Essences, Oxnard, CA, 93030 NDC 69779-020-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0383-2025·2025-04-30

    Homeopathic Arnica Tablets Recalled for Manufacturing Process Deviations

    Pharmadel, LLC is recalling Rapidol Arnica Tablets due to cGMP deviations in the manufacturing process. No illnesses or injuries have been reported.

    Product
    Rapidol Arnica Tablets, Homeopathic Medicine, 100-count bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-405-99
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0376-2025·2025-04-30

    Topical ointment recalled for manufacturing practice deviations

    Apipharma is voluntarily recalling Kapsin Ointment due to manufacturing practice deviations identified at its Zagreb facility. The recall affects 5,095 cartons distributed in Arizona.

    Product
    Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronima Kavanjina 26, 10090 Zagreb, Croatia, Distributed by: Apipharma, LLC, 2331 West Alameda Drive, Tempe, AZ 85282 UPC 3 858882 101363
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0378-2025·2025-04-30

    FDA Issues Class II Recall of Clindamycin Capsules Due to Manufacturing Deviations

    RemedyRepack Inc. is voluntarily recalling 1,858 bottles of Clindamycin HCl 300 mg capsules due to Current Good Manufacturing Practice deviations. The product was distributed in Pennsylvania.

    Product
    Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0362-2025·2025-04-23

    Unisom SleepMinis diphenhydramine recalled for nitrosamine impurity

    Chattem Inc is recalling Unisom SleepMinis 25 mg capsules nationwide due to detection of N-nitroso-desmethyl-diphenhydramine impurity above the FDA Recommended Intake Limit. Approximately 129,240 bottles from two lots are affected.

    Product
    Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0343-2025·2025-04-16

    FDA Recalls Lacosamide Tablets for Manufacturing Quality Deviations

    Glenmark Pharmaceuticals is recalling Lacosamide 150mg tablets nationwide due to manufacturing quality deviations. Consumers should contact their pharmacy or healthcare provider regarding their supply.

    Product
    LACOSAMIDE — LACOSAMIDE (LACOSAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0337-2025·2025-04-16

    Lacosamide 50mg Tablets Recalled for Manufacturing Process Deviations

    Glenmark Pharmaceuticals is recalling Lacosamide 50mg tablets nationwide due to manufacturing process deviations. The affected lots (17240221 and 17240222) expire January 2026. No illnesses reported.

    Product
    LACOSAMIDE — LACOSAMIDE (LACOSAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0327-2025·2025-04-16

    Fluphenazine Hydrochloride Drug Recall Due to Manufacturing Process Deviations

    Glenmark Pharmaceuticals is recalling Fluphenazine Hydrochloride Tablets 2.5mg nationwide due to manufacturing deviations. The company initiated this voluntary Class II recall after determining that production did not meet FDA standards.

    Product
    FLUPHENAZINE HYDROCHLORIDE — FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0315-2025·2025-04-16

    Prescription Cardiac Drug Recalled for Manufacturing Quality Deviations Nationwide

    Glenmark Pharmaceuticals is recalling Propafenone Hydrochloride Extended-Release Capsules 225mg nationwide due to Current Good Manufacturing Practice deviations. The firm-initiated voluntary recall affects a single lot (17230819, expiring March 2025).

    Product
    PROPAFENONE HYDROCHLORIDE — PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0342-2025·2025-04-16

    Glenmark Diltiazem Extended-Release Capsules recalled for manufacturing deviations

    Glenmark Pharmaceuticals is voluntarily recalling Diltiazem Hydrochloride 120mg Extended-Release Capsules nationwide due to manufacturing process deviations. Consumers should verify lot numbers and consult their pharmacist.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0314-2025·2025-04-16

    Fenofibrate 67mg Capsules Recalled for Manufacturing Practice Deviations

    Glenmark Pharmaceuticals is recalling Fenofibrate 67mg capsules distributed nationwide due to manufacturing process deviations. The recall affects lots 17230834 and 17230835 with expiration dates of March 2025.

    Product
    FENOFIBRATE — FENOFIBRATE (FENOFIBRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0317-2025·2025-04-16

    Solifenacin succinate tablets recalled nationwide for manufacturing practice deviations

    Glenmark Pharmaceuticals is recalling solifenacin succinate 10mg tablets nationwide due to manufacturing process deviations. The voluntary recall affects specific lot numbers distributed across the United States.

    Product
    SOLIFENACIN SUCCINATE — SOLIFENACIN SUCCINATE (SOLIFENACIN SUCCINATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0330-2025·2025-04-16

    Lacosamide Tablets Recalled Due to Manufacturing Practice Deviations

    Glenmark Pharmaceuticals is recalling Lacosamide 100mg tablets nationwide due to manufacturing practice deviations. This is a voluntary recall initiated by the manufacturer.

    Product
    LACOSAMIDE — LACOSAMIDE (LACOSAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0348-2025·2025-04-16

    Cetirizine HCL tablets recalled for manufacturing process deviations

    Glenmark Pharmaceuticals is voluntarily recalling Cetirizine HCL 10mg tablets distributed nationwide. The recall was initiated due to Current Good Manufacturing Practice deviations.

    Product
    CETIRIZINE HCL — CETIRIZINE HCL (CETIRIZINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0316-2025·2025-04-16

    Propafenone Hydrochloride Extended-Release Capsules Recalled for Manufacturing Deviations

    Glenmark Pharmaceuticals is recalling Propafenone Hydrochloride Extended-Release Capsules 325mg nationwide due to Current Good Manufacturing Practice deviations. No illness or injury has been reported.

    Product
    PROPAFENONE HYDROCHLORIDE — PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0340-2025·2025-04-16

    Glenmark Recalls Colesevelam Hydrochloride Tablets Due to Manufacturing Deviations

    Glenmark Pharmaceuticals is voluntarily recalling specific lots of Colesevelam Hydrochloride Tablets due to manufacturing process deviations. The FDA classified this as a Class II recall affecting nationwide distribution.

    Product
    COLESEVELAM HYDROCHLORIDE — COLESEVELAM HYDROCHLORIDE (COLESEVELAM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0341-2025·2025-04-16

    Drug Recall: Pravastatin Sodium Due to Manufacturing Deviations

    Glenmark Pharmaceuticals is recalling certain Pravastatin Sodium tablets nationwide due to manufacturing process deviations. Affected lots with expiration dates between March and November 2026 were distributed throughout the United States.

    Product
    PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0344-2025·2025-04-16

    Clindamycin Hydrochloride Capsules Recalled for Manufacturing Practice Deviations

    Glenmark Pharmaceuticals Inc. USA is recalling Clindamycin Hydrochloride Capsules, USP 300mg due to CGMP deviations. The product has been distributed nationwide.

    Product
    CLINDAMYCIN HYDROCHLORIDE — CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0323-2025·2025-04-16

    Glenmark Rufinamide Tablets Recalled for Manufacturing Process Deviations

    Glenmark Pharmaceuticals is recalling Rufinamide 200mg tablets nationwide due to manufacturing process deviations. The voluntary recall affects certain lot numbers with July 2025 expiration dates.

    Product
    RUFINAMIDE — RUFINAMIDE (RUFINAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0352-2025·2025-04-16

    Propafenone Hydrochloride Capsules Recalled Due to Manufacturing Deviations

    Glenmark Pharmaceuticals recalls Propafenone Hydrochloride Extended-Release Capsules (325mg) nationwide due to manufacturing quality violations. Affected lot #17230767 expires March 2025.

    Product
    PROPAFENONE HYDROCHLORIDE — PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide