The Recall Desk

Hazard

Manufacturing Deviation recalls

314 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 manufacturing 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.

51–75 of 314

  • HighFDA (Drugs)·D-0347-2025·2025-04-16

    OTC Acetaminophen and Ibuprofen Tablets Recalled for Manufacturing Quality Deviations

    Glenmark Pharmaceuticals is recalling acetaminophen-ibuprofen tablets due to manufacturing quality deviations. No illnesses reported. Distributed nationwide via Amazon and Walmart.

    Product
    ACETAMINOPHEN, IBUPROFEN — ACETAMINOPHEN, IBUPROFEN (ACETAMINOPHEN, IBUPROFEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0351-2025·2025-04-16

    Drug Recall: Propafenone Hydrochloride Capsules Due to Manufacturing Deviations

    Glenmark Pharmaceuticals has voluntarily recalled Propafenone Hydrochloride Extended-Release Capsules (225mg, lot 17230819) due to manufacturing quality control deviations. The recall affects product distributed nationwide in the United States.

    Product
    PROPAFENONE HYDROCHLORIDE — PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0361-2025·2025-04-16

    Chlorpromazine Hydrochloride tablets recalled for excess chemical impurity

    Zydus Pharmaceuticals is recalling Chlorpromazine Hydrochloride tablets (10 mg) due to elevated levels of N-Nitroso-Desmethyl Chlorpromazine impurity from manufacturing deviations.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0326-2025·2025-04-16

    Fluphenazine Hydrochloride Tablets Recalled for Manufacturing Deviations

    Glenmark Pharmaceuticals is voluntarily recalling Fluphenazine Hydrochloride Tablets due to manufacturing practice deviations. Affected lot is 17232206 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

    Glenmark Gabapentin 600mg tablets recalled for manufacturing deviations

    Glenmark Pharmaceuticals is recalling Gabapentin 600mg tablets nationwide due to manufacturing practice deviations. No illnesses or injuries have been reported in connection with this recall.

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

    Metformin Tablets Recalled Due to Manufacturing Practice Deviations

    Glenmark Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release 1000mg tablets nationwide due to manufacturing process deviations. Affected lots 17232088 and 17232093 expire September 2025.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0350-2025·2025-04-16

    Pravastatin Sodium Tablets Recalled Due to Manufacturing Practice Deviations

    Glenmark Pharmaceuticals is voluntarily recalling Pravastatin Sodium 80mg tablets due to Current Good Manufacturing Practice deviations. The nationwide recall affects specific lot numbers and remains ongoing.

    Product
    PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0332-2025·2025-04-16

    Saxagliptin 5mg Tablets Recalled for Manufacturing Practice Deviations

    Glenmark Pharmaceuticals is voluntarily recalling Saxagliptin 5mg tablets nationwide due to CGMP deviations. Affected lot numbers are 17232460 and 17241194.

    Product
    SAXAGLIPTIN — SAXAGLIPTIN (SAXAGLIPTIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0325-2025·2025-04-16

    FDA recalls Glenmark Pravastatin Sodium tablets for manufacturing deviations

    Glenmark Pharmaceuticals Inc. is recalling Pravastatin Sodium 80mg tablets nationwide due to CGMP manufacturing deviations. Affected lots distributed to U.S. pharmacies expire from August 2025 through August 2026.

    Product
    PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0307-2025·2025-04-09

    Voriconazole Tablets Recalled Due to Manufacturing Practice Deviations

    Amerisource Health Services is recalling Voriconazole 50 mg tablets distributed nationwide due to current Good Manufacturing Practice deviations related to repackaging.

    Product
    VORICONAZOLE — VORICONAZOLE (VORICONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0264-2025·2025-03-19

    Latanoprost medication recalled due to manufacturing practice deviations

    Aspen Biopharma Labs is recalling Latanoprost medication due to manufacturing practice deviations. The voluntary recall affects product distributed to distributors in Hong Kong and Florida.

    Product
    Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0260-2025·2025-03-19

    Bimatoprost drug recalled for manufacturing quality deviations

    Aspen Biopharma Labs is recalling Bimatoprost due to manufacturing practice deviations. The recall is voluntary and affects product distributed to wholesalers.

    Product
    Bimatoprost NDC# 82187-1001-1 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-0233-2025·2025-02-26

    Prescription Atomoxetine capsules recalled for N-Nitroso impurity

    Glenmark Pharmaceuticals is recalling Atomoxetine 25 mg capsules nationwide due to the presence of N-Nitroso Atomoxetine impurity above FDA-recommended limits. Approximately 175,920 bottles are affected.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0238-2025·2025-02-26

    Atomoxetine Capsules Recalled for Chemical Impurity Above FDA Limits

    Glenmark Pharmaceuticals is recalling 120,000 bottles of Atomoxetine 10 mg capsules nationwide due to N-nitroso Atomoxetine impurity exceeding FDA recommended limits. Multiple lot numbers are affected with expiration dates through July 2026.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0212-2025·2025-02-05

    Duloxetine Delayed-Release Capsules recalled nationwide for nitrosamine impurity

    Duloxetine Delayed-Release Capsules USP 20 mg are being recalled nationwide due to presence of nitrosamine impurity above FDA acceptable limits. No adverse events have been reported.

    Product
    Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0185-2025·2025-01-15

    Medroxyprogesterone Acetate Injectable Suspension Recalled for Manufacturing Deviations

    Eugia US LLC is recalling medroxyprogesterone acetate injectable suspension (150mg/mL) due to manufacturing practice deviations. This voluntary recall affects 19,872 vials distributed nationwide.

    Product
    MEDROXYPROGESTERONE ACETATE — MEDROXYPROGESTERONE ACETATE (MEDROXYPROGESTERONE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0188-2025·2025-01-15

    Duloxetine Delayed-Release Capsules recalled for manufacturing deviation and impurity

    Rising Pharma is recalling certain batches of Duloxetine Delayed-Release Capsules 30 mg due to a manufacturing deviation that resulted in elevated N-nitroso-duloxetine impurity above FDA's recommended interim limit.

    Product
    Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0160-2025·2025-01-01

    Chlorpromazine Hydrochloride tablets recalled for manufacturing impurity excess

    Glenmark Pharmaceuticals is recalling Chlorpromazine Hydrochloride tablets due to manufacturing deviations that resulted in an impurity exceeding FDA limits. The affected lot (17230133, expiring 12/31/2024) was distributed nationwide.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0163-2025·2025-01-01

    DULoxetine tablets recalled for excess nitrosamine impurity

    PD-Rx Pharmaceuticals recalls DULoxetine DR 30 mg tablets due to excess nitrosamine impurity above acceptable limits. The affected lots were distributed in Florida, Mississippi, and Wisconsin.

    Product
    DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-0130-2025·2024-12-18

    Prescription drug Dabigatran Etexilate recalled for elevated nitrosamine impurity

    Ascend Laboratories is recalling Dabigatran Etexilate 150mg capsules due to elevated N-nitroso-Dabigatran impurity from a manufacturing deviation. Affected lots were distributed nationwide; consult your physician before making changes to your medication.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0097-2025·2024-12-11

    Diltiazem extended-release capsules recalled for manufacturing impurity

    Glenmark Pharmaceuticals is recalling 4,704 bottles of Diltiazem Hydrochloride extended-release capsules 90mg due to manufacturing contamination with an impurity above FDA limits. Two lot numbers distributed nationwide are affected.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0110-2025·2024-12-11

    Cinacalcet Tablets Recalled Due to Nitrosamine Impurity Exceeding Limits

    AvKARE is recalling 2,796 bottles of Cinacalcet Tablets (90 mg) nationwide due to manufacturing deviations resulting in N-Nitroso-Cinacalcet above acceptable intake limits.

    Product
    Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0106-2025·2024-12-11

    Duloxetine Delayed-Release Capsules Recalled for N-Nitroso Impurity Above Limits

    Rising Pharma is recalling 122,925 bottles of Duloxetine 30 mg capsules nationwide due to a manufacturing deviation: the presence of N-nitroso-duloxetine impurity above the recommended interim limit.

    Product
    Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0111-2025·2024-12-11

    Pigmentation treatment product recalled for manufacturing process deviations

    Only Your Rx pigmentation product is being recalled due to manufacturing quality deviations in water systems used during production. The product was distributed in California only.

    Product
    10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your Rx, Nature + Science, 1 fl. oz., 30 mL Bottle, For Professional Use Only, Only YourRx Inc., Chatsworth, CA 91311, Made in USA, Onlyyourrx.com.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0071-2025·2024-12-04

    FDA Recalls Cheeky Bonsai Menthol Pain Relief Patches for Manufacturing Deviations

    Cheeky Bonsai Pain Relief Patches (Menthol 10%) are being recalled nationwide due to manufacturing facility compliance deviations. The voluntary recall affects 17,928 patches distributed across the US.

    Product
    CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8 60006 57564 9
    Category
    Drug
    Distribution
    Distributed nationwide