The Recall Desk

Hazard

Manufacturing Deviation recalls

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

What the numbers show

Total
294
Critical
0
Severe
6
Most recent
2026-07-08

Of the 294 manufacturing deviation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (2%) are Severe.

Which agencies issued them

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.

1–25 of 294

  • ModerateFDA (Drugs)·D-0657-2026·2026-07-08

    Synjardy XR Tablets Recalled Due to Manufacturing Deviations

    Boehringer Ingelheim Pharmaceuticals is recalling one lot of Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg due to manufacturing deviations involving incorrect detergent use and missing swab sampling.

    Product
    Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 00597-0300-45
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0522-2026·2026-05-13

    Duloxetine delayed-release capsules recalled for N-nitroso impurity contamination

    Breckenridge Pharmaceutical is recalling Duloxetine Delayed-Release Capsules 60mg due to the presence of N-nitroso-duloxetine impurity above FDA recommended limits. The affected product was distributed nationwide.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0508-2026·2026-05-06

    Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations

    Wells Pharma is recalling fentanyl citrate injectable solution (50 mcg/5mL, NDC 73702-202-15) nationwide due to cGMP manufacturing deviations. The recall affects 50 syringes from Lot 020226202150202 with expiration date 05/05/2026.

    Product
    fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0500-2026·2026-05-06

    iVIZIA Dry Eye Lubricant Drops Recalled for Sterility Assurance

    Thea Pharma, Inc. is recalling iVIZIA Dry Eye (Povidone 0.5%) lubricant eye drops nationwide due to the FDA's discovery of manufacturing process deviations that affect the product's sterility assurance.

    Product
    IVIZIA DRY EYE — IVIZIA DRY EYE (POVIDONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0486-2026·2026-04-29

    Furosemide tablets recalled for presence of N-nitroso impurity

    Leading Pharma, LLC is recalling Furosemide 80 mg tablets due to the presence of N-nitroso-Furosemide (NNF) above the recommended intake limit, caused by manufacturing deviations.

    Product
    FUROSEMIDE — FUROSEMIDE (FUROSEMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1008-2026·2026-01-07

    Laser and endoscopy systems recalled over ferrites omitted from a USB cable

    Beaver-Visitec International is recalling 5 BVI Leos Laser and Endoscopy Systems because ferrites specified for the USB cable assembly were not installed as intended.

    Product
    BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0471-2025·2025-06-25

    Amazon Basic Care Acetaminophen 325 mg Tablets Recalled Due to Discoloration

    Aurobindo Pharma USA Inc is recalling Amazon Basic Care Acetaminophen 325 mg tablets due to confirmed consumer complaints of brown surface discoloration on tablets, a cGMP deviation.

    Product
    AMAZON BASIC CARE ACETAMINOPHEN — AMAZON BASIC CARE ACETAMINOPHEN (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0428-2025·2025-05-28

    Rapidol Hydrocortisone 1% Anti-Itch Cream Recalled for CGMP Deviations

    Kenil Healthcare is recalling 10,000 tubes of Rapidol Maximum Strength Hydrocortisone 1% Anti-Itch Cream (2 oz, Lot SP26A, Expiration 09/30/2026) distributed in Delaware and North Carolina due to manufacturing quality issues.

    Product
    RAPIDOL — RAPIDOL (HYDROCORTISONE)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0382-2025·2025-04-30

    Rapidol Arnica Gel topical homeopathic medicine recalled for manufacturing violations

    Pharmadel, LLC is recalling Rapidol Arnica Gel (2 oz, 57 g) distributed in Delaware due to manufacturing process deviations. The voluntary recall affects 6,048 bottles of lot EAG-01 with expiration date MAR 27.

    Product
    Rapidol Arnica Gel, Topical Gel, Homeopathic Medicine, 2 oz (57 g), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-403-02
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0388-2025·2025-04-30

    Duloxetine Delayed-Release Capsules Recalled for Nitrosamine Impurity

    Breckenridge Pharmaceutical is recalling Duloxetine Delayed-Release Capsules 30 mg nationwide due to the presence of a nitrosamine drug substance related impurity above proposed interim limits.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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
  • 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-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
    1 state
  • 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
    1 state
  • 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-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-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-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-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