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.

101–125 of 547

  • 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-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
  • 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-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-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
    0 states
  • 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
    0 states
  • 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-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
  • 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
  • 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-0093-2025·2024-12-11

    Diltiazem Hydrochloride Capsules Recalled Due to Manufacturing Impurity

    Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride Extended-Release Capsules (60 mg) due to presence of N-nitroso-Desmethyl-Diltiazem impurity exceeding FDA limits. Approximately 34,848 bottles nationwide are affected.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0105-2025·2024-12-11

    Duloxetine Delayed-Release Capsules Nationwide Recall for N-Nitroso Impurity

    Rising Pharma recalls Duloxetine Delayed-Release Capsules 20 mg nationwide due to N-nitroso-duloxetine impurity exceeding recommended interim limits, affecting 209,376 bottles.

    Product
    Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
    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 — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0087-2025·2024-12-11

    MAXIM Assure Antibacterial Hand Soap Recalled for Microbial Contamination

    Midlab Incorporated is recalling MAXIM Assure Antibacterial hand soap (Lot 0711241) nationwide due to out-of-specification microbial test results in the manufacturing process.

    Product
    MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutional Use Only, MIDLAB 140 Private Brand Way, Athens, TN 37303
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0063-2025·2024-12-04

    Drug recall: Absorbine Jr. Ultra Strength Pain Patch manufacturing deviations

    Absorbine Jr. Ultra Strength Pain Patch is being recalled nationwide due to manufacturing process deviations. The voluntary recall affects approximately 4,968,000 patches.

    Product
    ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By: Absorbine Jr. LLC, Chattanooga, TN 37402 UPC 8 89476 41318 3, UPC 8 89476 41336 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0639-2024·2024-08-28

    Rubbing Alcohol Recalled for Non-Sterile Water in Manufacturing

    ZEE Company's 70% isopropyl rubbing alcohol is being recalled because non-sterile water was used in production instead of sterile water, violating manufacturing standards. The product was distributed nationwide in the US and Canada.

    Product
    Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon drum), Sold by: ZEE Company- A Member of the Vincit Group, 3401 Cummings Road, Chattanooga, TN 37419, Made in USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0640-2024·2024-08-28

    HAND-I-SAN Hand Sanitizer Recalled for Manufacturing Process Deviation

    HAND-I-SAN No-Rinse Hand Sanitizer is being recalled due to manufacturing process deviations involving the use of non-sterile water in production. The product was distributed nationwide and to Canada.

    Product
    HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4x1 gallon jugs), b) 18.92L (5-gallon pail), c) 208.19L (55-gallon drum), and d) 1040.98L (275-gallon tote), ZEE Company 3401 Cummings Road, Chattanooga, TN, 374
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0570-2024·2024-07-10

    Budesonide USP drug ingredient recalled for glass contamination

    Medisca Inc. is recalling 113 bottles of Budesonide, USP (Micronized) 500 mg due to glass particulate matter contamination caused by manufacturing deviations. The product was distributed nationwide in the USA and Canada.

    Product
    Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0576-2024·2024-07-10

    Drug Recall: Little Moon Essentials Ass Kisser due to CGMP Deviations

    Little Moon Essentials is voluntarily recalling Ass Kisser due to CGMP deviations identified in the manufacturing process. The recall affects 165 metal tins distributed nationwide in the USA and Canada.

    Product
    Little Moon Essentials, Ass Kisser, Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88228 2, NDC 70722-208-05; b) 3 OZ (85.05G) metal tin, UPC Code 6 73673 88208 4, NDC 70722-208-03; Little Moon Essentials LLC Dania Beach, Fl 33004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0571-2024·2024-07-10

    Drug Recall: Little Moon Essentials Magical Muscle Oil due to CGMP Deviations

    Little Moon Essentials is recalling Magical Muscle Oil due to manufacturing practice deviations. The recall affects 1,654 glass jars distributed nationwide in the USA and Canada.

    Product
    Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) packaged as: a) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88202 2, NDC 70722-246-02; b) 4 FL OZ (118ML) jar, UPC Code 6 73673 88233 6, NDC 70722-246-04; Little Moon Essentials LLC Dania Beach, Fl 33004
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0557-2024·2024-06-26

    Little Remedies Gas Relief Drops Class II Recall for Manufacturing Deviations

    Denison Pharmaceuticals recalls 113,544 bottles of Little Remedies Gas Relief Drops (Lot #0855, exp. 8/31/2025) due to manufacturing deviations. All units have been recovered and controlled at the manufacturer.

    Product
    LITTLE REMEDIES — LITTLE REMEDIES (SIMTHICONE)
    Category
    Drug
    Distribution
    0 states