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.

276–300 of 1563

  • ModerateFDA (Drugs)·D-0381-2025·2025-04-30

    Kingskin Salicylic Acid Wart Removal Recall Due to cGMP Deviations

    Pharmadel, LLC is recalling Kingskin salicylic acid wart-removal solution due to cGMP manufacturing deviations. The recall affects 20,048 bottles distributed in Delaware.

    Product
    KINGSKIN — KINGSKIN (SALICYLIC ACID)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0376-2025·2025-04-30

    Kapsin Ointment Drug Recalled Due to Manufacturing Process Deviations

    Apipharma is voluntarily recalling Kapsin Ointment (Camphor 3.16% and Capsaicin 0.03%) distributed in Arizona due to Current Good Manufacturing Practice (CGMP) deviations.

    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

    Clindamycin HCl 300 mg Capsule Recalled for CGMP Deviations

    RemedyRepack Inc. is recalling Clindamycin HCl 300 mg Capsules due to current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 1,858 30-count blister cards 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
  • ModerateFDA (Drugs)·D-0379-2025·2025-04-30

    DoloDent Maximum Strength Toothache Drops Recalled for cGMP Deviations

    Pharmadel, LLC is recalling DoloDent Maximum Strength Toothache Drops due to current Good Manufacturing Practice (cGMP) deviations. The voluntary recall affects 9,504 bottles distributed in Delaware.

    Product
    DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-400-15
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0386-2025·2025-04-30

    Bimatoprost Bulk Powder Recalled by Medisca for CGMP Deviations

    Medisca Inc. is voluntarily recalling Bimatoprost bulk powder in three sizes due to manufacturing process deviations. The powder was distributed nationwide.

    Product
    Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) drums, Medisca, Plattsburgh, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0383-2025·2025-04-30

    Rapidol Arnica Tablets recalled due to manufacturing deviations

    Pharmadel is recalling 6,048 bottles of Rapidol Arnica Tablets homeopathic medicine due to current good manufacturing practice (cGMP) deviations. The recall affects bottles with lot EAT-01, expiration date March 27, distributed in Delaware.

    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-0366-2025·2025-04-23

    Chlorpromazine Hydrochloride Tablets Recalled Due to Impurity

    The FDA is recalling Chlorpromazine Hydrochloride Tablets, 10 mg, due to the presence of N-Nitroso-Desmethyl Chlorpromazine impurity above recommended limits. The affected lot was distributed nationwide.

    Product
    ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0362-2025·2025-04-23

    Unisom SleepMinis diphenhydramine capsules recalled for nitrosamine impurity

    Chattem Inc. is recalling Unisom SleepMinis 25 mg diphenhydramine capsules due to detection of nitrosamine impurity above FDA limits. Affected lots are 22L603 (exp. Oct 2025) and 378999 (exp. Feb 2027).

    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
  • SevereFDA (Drugs)·D-0361-2025·2025-04-16

    Chlorpromazine Hydrochloride Tablets Recalled Due to Impurity

    Zydus Pharmaceuticals is recalling chlorpromazine hydrochloride 10 mg tablets due to the presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit. The recall affects 3,144 bottles distributed nationwide.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    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
  • ModerateFDA (Drugs)·D-0324-2025·2025-04-16

    Nitroglycerin Sublingual Tablets Recalled for CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA is recalling Nitroglycerin Sublingual Tablets 0.4 MG due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects specific lot numbers distributed nationwide.

    Product
    NITROGLYCERIN — NITROGLYCERIN (NITROGLYCERIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0320-2025·2025-04-16

    Gabapentin 600mg Tablets Recalled for CGMP Deviations

    Glenmark Pharmaceuticals Inc. is voluntarily recalling Gabapentin 600mg tablets (500-count bottles) nationwide due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.

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

    Fluphenazine Hydrochloride Tablets 2.5mg Recalled by Glenmark Pharmaceuticals

    Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Fluphenazine Hydrochloride Tablets 2.5mg nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The affected lot is 17232214 with expiration date September 2025.

    Product
    FLUPHENAZINE HYDROCHLORIDE — FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0328-2025·2025-04-16

    Metformin Hydrochloride Extended-Release Tablets Recalled for CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA is recalling Metformin Hydrochloride Extended-Release Tablets 1000mg due to manufacturing practice deviations. The recall affects 90-count bottles distributed nationwide and is voluntary.

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

    Propafenone Hydrochloride Extended-Release Capsules Recalled for CGMP Deviations

    Glenmark Pharmaceuticals Inc. is recalling Propafenone Hydrochloride Extended-Release Capsules 325mg (Lot #17230767, expiring Mar-25) distributed nationwide due to current Good Manufacturing Practice (CGMP) deviations. Patients taking this medication should consult their physician before discontinuing use.

    Product
    PROPAFENONE HYDROCHLORIDE — PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0334-2025·2025-04-16

    Teriflunomide Tablets 14mg Recalled for CGMP Manufacturing Deviations

    Glenmark Pharmaceuticals Inc. is voluntarily recalling Teriflunomide 14mg tablets (Lot #17232462, expiring Nov-25) distributed nationwide due to current good manufacturing practice (CGMP) deviations discovered during production.

    Product
    TERIFLUNOMIDE — TERIFLUNOMIDE (TERIFLUNOMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0346-2025·2025-04-16

    Naproxen Sodium tablets recalled due to manufacturing compliance deviations

    Glenmark Pharmaceuticals Inc., USA is recalling Naproxen Sodium Tablets, USP 550mg nationwide due to CGMP (Current Good Manufacturing Practice) deviations identified during manufacturing. The recall affects lot #17231956 with expiration date Aug-25.

    Product
    NAPROXEN SODIUM — NAPROXEN SODIUM (NAPROXEN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0314-2025·2025-04-16

    Fenofibrate Capsules Recalled for CGMP Manufacturing Deviations

    Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Fenofibrate Capsules 67 mg due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 100-count bottles distributed nationwide.

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

    Colesevelam Hydrochloride Tablets Recalled for CGMP Deviations

    Glenmark Pharmaceuticals Inc. is recalling Colesevelam Hydrochloride 625mg tablets nationwide due to CGMP deviations. The firm initiated this Class II voluntary recall; no illnesses or injuries have been reported.

    Product
    COLESEVELAM HYDROCHLORIDE — COLESEVELAM HYDROCHLORIDE (COLESEVELAM HYDROCHLORIDE)
    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-0352-2025·2025-04-16

    Propafenone Hydrochloride Extended-Release Capsules Recalled for CGMP Deviations

    Glenmark Pharmaceuticals is voluntarily recalling Propafenone Hydrochloride Extended-Release Capsules 325mg (Lot #17230767, exp. Mar-25) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    PROPAFENONE HYDROCHLORIDE — PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0337-2025·2025-04-16

    Lacosamide Tablets 50mg Recalled for CGMP Manufacturing Deviations

    Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Lacosamide Tablets 50mg due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects specific lots distributed nationwide.

    Product
    LACOSAMIDE — LACOSAMIDE (LACOSAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0319-2025·2025-04-16

    Voriconazole Tablets 50mg Recalled Due to CGMP Deviations

    Glenmark Pharmaceuticals Inc. USA is recalling Voriconazole Tablets 50mg (Lot # 17231045, exp. date Apr-25) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.

    Product
    VORICONAZOLE — VORICONAZOLE (VORICONAZOLE)
    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-0333-2025·2025-04-16

    Solifenacin Succinate Tablets Recalled Due to Manufacturing Deviations

    Glenmark Pharmaceuticals Inc., USA is recalling Solifenacin Succinate 5mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall is voluntary and affects 30-count and 90-count bottles distributed across the U.S.

    Product
    SOLIFENACIN SUCCINATE — SOLIFENACIN SUCCINATE (SOLIFENACIN SUCCINATE)
    Category
    Drug
    Distribution
    Distributed nationwide