The Recall Desk

Hazard

Cgmp Deviation recalls

1,552 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,552
Critical
1
Severe
283
Most recent
2026-09-02

Of the 1,552 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 283 (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 1552

  • 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-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-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-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-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-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-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
  • 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-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-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-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-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-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-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-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-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-0375-2025·2025-04-30

    Hemopropin Ointment Recalled Due to Manufacturing Process Deviations

    Apipharma is voluntarily recalling Hemopropin Ointment due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The recall affects specific lot numbers distributed in Arizona.

    Product
    Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o, Croatia, Distributed by: Apipharma, LLC, Tempe, AZ UPC 3 858882 103534 and UPC 3 858882 101318
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0380-2025·2025-04-30

    DoloEar Homeopathic Earache Drops Recalled for cGMP Deviations

    Pharmadel, LLC is recalling DoloEar Homeopathic Earache Drops (0.50 oz, 15 mL) due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 27,648 bottles distributed in Delaware.

    Product
    DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15
    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