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.

251–275 of 1563

  • SevereFDA (Drugs)·D-0451-2025·2025-06-04

    Carvedilol Tablets 25 mg Recalled Due to Impurity Above Acceptable Limit

    Glenmark Pharmaceuticals is recalling Carvedilol Tablets USP 25 mg nationwide due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit, resulting from CGMP deviations.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0425-2025·2025-05-28

    KOFAL Original Pain Relieving Ointment Recalled for CGMP Deviations

    KENIL HEALTHCARE PRIVATE LIMITED is recalling KOFAL Original Penetrating Pain Relieving Ointment (methyl salicylate 12%) due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 16,248 jars distributed in Delaware and North Carolina.

    Product
    KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz (113 g) Jar, Distributed by: Pharmadel LLC, Georgetown, DE 199747, NDC 55758-106-04, UPC 8 9971100128 0.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0423-2025·2025-05-28

    Antifungal Cream Recalled for Manufacturing Deviations

    Kenil Healthcare is recalling CURA HONGOS Antifungal Cream (Clotrimazole 1%, 2 oz tubes) distributed in Delaware and North Carolina due to CGMP (Current Good Manufacturing Practice) deviations detected during manufacturing.

    Product
    CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 997110 011052.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0436-2025·2025-05-28

    Nature Mint Anticavity Fluoride Toothpaste Recall Due to CGMP Deviations

    KENIL HEALTHCARE PRIVATE LIMITED is voluntarily recalling Nature Mint Anticavity Fluoride Toothpaste due to Current Good Manufacturing Practice (CGMP) deviations. The affected toothpaste was distributed in Delaware and North Carolina.

    Product
    Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.6 OZ (17g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-02
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0446-2025·2025-05-28

    Phentermine Hydrochloride Capsules 30mg Recalled for cGMP Deviations

    KVK Tech, Inc. is recalling 9,680 bottles of Phentermine Hydrochloride Capsules 30mg nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall is voluntary and firm-initiated.

    Product
    PHENTERMINE HYDROCHLORIDE — PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0434-2025·2025-05-28

    Maximum Security Anticavity Gel Toothpaste recalled for CGMP deviations

    Maximum Security Anticavity Gel Toothpaste (Sodium Fluoride 0.22%, Fresh Mint) distributed in Delaware and North Carolina is being recalled due to CGMP deviations identified by the manufacturer.

    Product
    Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 1.5 OZ (43 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-04
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0429-2025·2025-05-28

    Rapidol Triple Antibiotic Ointment Recalled for CGMP Deviations

    Rapidol Triple Antibiotic First Aid Ointment (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate) distributed in Delaware and North Carolina is being recalled for CGMP deviations. The manufacturer initiated a voluntary recall of 9,336 tubes.

    Product
    RAPIDOL — RAPIDOL (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0421-2025·2025-05-28

    Artridon Topical Analgesic Recalled for Manufacturing Process Deviations

    Kenil Healthcare is recalling 9,984 tubes of Artridon topical analgesic (menthol and methyl salicylate) due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects units distributed in Delaware and North Carolina.

    Product
    ARTRIDON — ARTRIDON (MENTHOL, METHYL SALICYLATE)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0445-2025·2025-05-28

    Indomethacin Extended-Release Capsules Recalled for cGMP Deviations

    KVK Tech, Inc. is recalling Indomethacin Extended-Release Capsules USP, 75 mg (Lot #18400A) nationwide due to cGMP deviations. The recall affects approximately 9,107 bottles distributed nationwide.

    Product
    INDOMETHACIN — INDOMETHACIN (INDOMETHACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0430-2025·2025-05-28

    Cinnafresh Anticavity Gel Toothpaste Recalled Due to CGMP Deviations

    Cinnafresh anticavity gel toothpaste (sodium fluoride 0.22%, Bold Cinnamon Flavor) is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer, KENIL HEALTHCARE PRIVATE LIMITED, initiated this voluntary recall.

    Product
    Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-133-01
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0424-2025·2025-05-28

    Kingskin SacaCallos salicylic acid solution recalled for manufacturing deviations

    Kingskin SacaCallos 17% salicylic acid bottles are being recalled due to manufacturing deviations. The firm initiated the voluntary recall affecting approximately 9,000 bottles distributed in Delaware and North Carolina.

    Product
    Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-423-15, UPC 8 10096 77163 6.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0438-2025·2025-05-28

    Nature Mint Anticavity Fluoride Toothpaste Recall Due to Manufacturing Deviations

    KENIL HEALTHCARE PRIVATE LIMITED is recalling Nature Mint Anticavity Fluoride Toothpaste (0.85 oz tubes) distributed in Delaware and North Carolina due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-03
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0437-2025·2025-05-28

    Nature Mint Anticavity Fluoride Toothpaste recall due to manufacturing deviations

    KENIL HEALTHCARE PRIVATE LIMITED is recalling Nature Mint Anticavity Fluoride Toothpaste (6.4 oz, Lot B0067, expiring 08/31/2026) distributed in Delaware and North Carolina due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 6.4 OZ (181 grams) Box, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-07
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0439-2025·2025-05-28

    Nature Mint Anticavity Fluoride Toothpaste Recalled for CGMP Deviations

    KENIL HEALTHCARE PRIVATE LIMITED is recalling Nature Mint Anticavity Fluoride Toothpaste due to manufacturing deviations. The recall affects 150,768 tubes distributed in Delaware and North Carolina.

    Product
    Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 1.5 OZ (43 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-04
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0426-2025·2025-05-28

    KOFAL Methyl Salicylate External Analgesic Ointment Recall

    KOFAL Athletes Penetrating Pain Relief external analgesic ointment (methyl salicylate 10.5%) is being recalled due to CGMP deviations in manufacturing. The voluntary recall affects 11,808 jars distributed in Delaware and North Carolina.

    Product
    KOFAL — KOFAL (METHYL SALICYLATE)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0431-2025·2025-05-28

    Maximum Security Anticavity Gel Toothpaste Recalled for CGMP Deviations

    Maximum Security Anticavity Gel Toothpaste is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 391,680 tubes distributed in Delaware and North Carolina.

    Product
    Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, Net Wt 0.6 OZ (17 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-02
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0440-2025·2025-05-28

    Nature Mint Anticavity Fluoride Toothpaste Recall CGMP Deviations

    Nature Mint Anticavity Fluoride Toothpaste (0.76% sodium monofluorophosphate, 2.75 OZ tube) is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The affected lots were distributed in Delaware and North Carolina.

    Product
    Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 2.75 OZ (78g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-05
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0432-2025·2025-05-28

    Maximum Security Anticavity Gel Toothpaste recalled for CGMP deviations

    Maximum Security Anticavity Gel Toothpaste is being recalled due to Current Good Manufacturing Practice (CGMP) deviations identified by the manufacturer. The recall affects toothpaste tubes distributed in Delaware and North Carolina.

    Product
    Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.85 oz (24 g) Tube, Made in India, Dist. by Bob Barker Co. Inc. Fuquay-Varnia, NC 27526, NDC 53247-132-03
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0433-2025·2025-05-28

    Maximum Security Anticavity Toothpaste Sachets Recalled for CGMP Deviations

    KENIL HEALTHCARE PRIVATE LIMITED is recalling Maximum Security Anticavity Gel Toothpaste sachets distributed in Delaware and North Carolina due to Current Good Manufacturing Practice (CGMP) deviations identified by the FDA.

    Product
    Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.15 OZ (4.25 g) Sachets, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-01
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0406-2025·2025-05-14

    Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns

    BRS Analytical Services is recalling Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% eye lubricant nationwide due to cGMP deviations and lack of assurance of sterility. The recalled product was distributed in 0.5 FL OZ dropper bottles across multiple lots with various expiration dates in 2025 and 2026.

    Product
    CARBOXYMETHYLCELLULOSE SODIUM — CARBOXYMETHYLCELLULOSE SODIUM (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0410-2025·2025-05-14

    Homeopathic Oral Spray Temper Tamer Recalled for CGMP Deviations

    Siddha Flower Essences is voluntarily recalling Temper Tamer homeopathic oral spray due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.

    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-0411-2025·2025-05-14

    Clindamycin HCl Capsule 300 mg repackaged by RemedyRePack Inc.

    RemedyRePack Inc. is recalling Clindamycin HCl Capsule, 300 mg, due to current Good Manufacturing Practice (CGMP) deviations—the products were manufactured in a shared facility with Ezetimibe tablets.

    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
  • ModerateFDA (Drugs)·D-0391-2025·2025-05-07

    Clindamycin Hydrochloride Capsules Recalled for cGMP Deviations

    Preferred Pharmaceuticals, Inc. is voluntarily recalling Clindamycin Hydrochloride Capsules USP 300mg due to manufacturing process deviations. The recall affects 1190 bottles distributed nationwide.

    Product
    Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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