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.

301–325 of 1563

  • 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-0322-2025·2025-04-16

    Frovatriptan Succinate tablets recalled due to manufacturing deviations

    Glenmark Pharmaceuticals Inc., USA is recalling Frovatriptan Succinate 2.5mg tablets nationwide due to current Good Manufacturing Practice (CGMP) deviations. The FDA has classified this as a Class II recall.

    Product
    FROVATRIPTAN SUCCINATE — FROVATRIPTAN SUCCINATE (FROVATRIPTAN SUCCINATE)
    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-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-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-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-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-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-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
  • 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-0331-2025·2025-04-16

    Nitroglycerin Sublingual Tablets Recalled for CGMP Deviations

    Glenmark Pharmaceuticals Inc. is recalling specific lots of Nitroglycerin 0.3MG sublingual tablets distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations. Patients should consult their healthcare provider.

    Product
    NITROGLYCERIN — NITROGLYCERIN (NITROGLYCERIN)
    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-0309-2025·2025-04-09

    Prescription Antipsychotic Drug Recalled for Manufacturing Impurity

    Glenmark Pharmaceuticals is recalling Chlorpromazine Hydrochloride Tablets due to a manufacturing quality deviation involving an impurity above recommended limits.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0263-2025·2025-03-19

    Chemotherapy drug Chlorambucil recalled for manufacturing process deviations

    Aspen Biopharma Labs is voluntarily recalling Chlorambucil due to manufacturing process deviations. The product was distributed to distributors in Hong Kong and Florida.

    Product
    Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0261-2025·2025-03-19

    Drug Recall: Alprostadil Affected by Manufacturing Practice Deviations

    Alprostadil 3.0 gm is being recalled due to manufacturing practice deviations. Limited distribution affects product with lot number HAALC0020922 (expiration August 2025).

    Product
    Alprostadil Container Description: Amber color bottle
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0270-2025·2025-03-19

    Duloxetine 30mg Delayed-Release Capsules Recalled for N-Nitroso Impurity

    Breckenridge Pharmaceutical recalls 14,749 bottles of duloxetine 30mg delayed-release capsules due to N-nitroso impurity above FDA safety limits. Patients taking this medication should contact their healthcare provider to verify if their prescription is affected.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0215-2025·2025-02-12

    Prescription Carvedilol recalled for manufacturing impurity exceeding FDA specifications

    Glenmark Pharmaceuticals is recalling Carvedilol 25 mg tablets nationwide due to a manufacturing quality issue with impurity levels exceeding FDA recommended limits. Multiple lot numbers and expiration dates from February 2025 through February 2026 are affected.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0206-2025·2025-01-29

    First Aid Beauty Ultra Repair Cream Recalled for CGMP Deviations

    First Aid Beauty is recalling Ultra Repair Cream due to CGMP (Current Good Manufacturing Practice) deviations. Product intended for quarantine was inadvertently distributed nationwide.

    Product
    First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0205-2025·2025-01-29

    Kissable Diabetics Foot Cream recalled nationwide for inadequate release testing

    Brands International Corporation is recalling Kissable Diabetics Foot Cream nationwide due to lack of adequate release testing during manufacturing. The FDA has classified this as a Class II recall.

    Product
    Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 72008 80925 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0190-2025·2025-01-15

    Duloxetine Drug Recall Due to Manufacturing Impurity Levels

    Rising Pharma recalls Duloxetine DR Capsules 60 mg nationwide due to N-nitroso-duloxetine impurity levels exceeding FDA limits. Affected batches were distributed nationwide; check lot numbers on bottle labels for affected product.

    Product
    Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0165-2025·2025-01-01

    Duloxetine delayed-release capsules recalled due to manufacturing impurity

    Duloxetine delayed-release 60mg capsules are being recalled nationwide due to N-nitroso-duloxetine impurity above recommended interim limits. Two lot numbers are affected: J0786744-061724 (blister cards) and B3002625-060524 (bottles).

    Product
    Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0159-2025·2025-01-01

    Prescription chlorpromazine tablets recalled due to manufacturing quality defect

    Glenmark Pharmaceuticals is recalling chlorpromazine hydrochloride 10mg tablets nationwide due to manufacturing deviations that allowed excess N-nitroso impurity.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0143-2025·2024-12-25

    Topical anesthetic gel recall due to manufacturing quality control deviation

    Keystone Industries recalls Burkhart Topical Anesthetic Gel due to CGMP deviations discovered during quality inspection. The product was inadvertently released despite being flagged for rejection.

    Product
    Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply, Tacoma, Washington 98409.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0129-2025·2024-12-18

    Dabigatran Etexilate 75 mg capsules recalled for N-nitroso impurity

    Ascend Laboratories is recalling Dabigatran Etexilate 75 mg capsules nationwide due to manufacturing deviations. Three lots contain N-nitroso-Dabigatran impurity above recommended interim limits.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0078-2025·2024-12-11

    Prescription Cinacalcet Tablets Recalled for N-Nitroso Impurity

    Aurobindo Pharma USA Inc is recalling Cinacalcet 60mg tablets nationwide due to N-nitroso Cinacalcet impurity exceeding FDA recommended interim limits.

    Product
    Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
    Category
    Drug
    Distribution
    Distributed nationwide