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.

226–250 of 314

  • HighFDA (Drugs)·D-1096-2022·2022-06-15

    FDA Recalls Depo-Medrol Injectable Due to Temperature Abuse in Manufacturing

    McKesson Medical-Surgical is recalling DEPO-MEDROL (methylprednisolone acetate) injectable suspension nationwide due to temperature abuse during manufacturing that may have affected product quality. No illnesses have been reported.

    Product
    DEPO-MEDROL — DEPO-MEDROL (METHYLPREDNISOLONE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1037-2022·2022-06-15

    Meclizine Hydrochloride Tablets Recalled for Manufacturing Temperature Control Deviations

    Mckesson Medical-Surgical is recalling Meclizine Hydrochloride 25mg tablets nationwide due to manufacturing deviations involving improper temperature control. The FDA classified this as a Class II recall.

    Product
    MECLIZINE HYDROCHLORIDE — MECLIZINE HYDROCHLORIDE (MECLIZINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1055-2022·2022-06-15

    Ibuprofen tablets recalled nationwide due to temperature abuse during manufacturing

    McKesson Medical-Surgical is recalling Ibuprofen 400 mg prescription tablets nationwide due to temperature abuse during manufacturing. The manufacturing deviation may affect drug stability and efficacy.

    Product
    IBUPROFEN — IBUPROFEN (IBUPROFEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1040-2022·2022-06-15

    FDA Recalls Ipratropium Bromide Inhalation Solution Due to Manufacturing Deviation

    McKesson Medical-Surgical is recalling Ipratropium Bromide Inhalation Solution nationwide due to current good manufacturing practice (cGMP) deviations involving temperature control. The FDA has classified this as a Class II recall.

    Product
    IPRATROPIUM BROMIDE — IPRATROPIUM BROMIDE (IPRATROPIUM BROMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1094-2022·2022-06-15

    Labetalol Hydrochloride Tablets Recalled for Temperature Abuse During Manufacturing

    McKesson Medical-Surgical is recalling Labetalol Hydrochloride Tablets 100 mg due to temperature abuse during manufacturing that may affect drug stability. This Class II recall affects units distributed nationwide.

    Product
    Labetalol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, MFG: Par Pharma, NDC 49884-122-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1057-2022·2022-06-15

    Promethazine HCl Tablets Recalled Due to Manufacturing Temperature Deviation

    McKesson Medical-Surgical is recalling Promethazine HCl Tablets, 25 mg, due to temperature deviations during manufacturing that did not comply with current good manufacturing practices. The recall affects 16 cartons distributed nationwide.

    Product
    Promethazine HCl Tablets, USP, 25 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6461-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1084-2022·2022-06-15

    FDA Class II Recall: E-Z-HD Barium Sulfate Oral Suspension Due to Temperature Abuse

    McKesson is recalling E-Z-HD (Barium Sulfate for Oral Suspension) due to temperature deviations during manufacturing. Healthcare providers should stop using the recalled product and contact the manufacturer for lot identification.

    Product
    E-Z-HD — E-Z-HD (BARIUM SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1099-2022·2022-06-15

    Drug recall: Thrombin JMI injection kits due to manufacturing temperature deviation

    McKesson Medical-Surgical is recalling 157 kits of Thrombin JMI nationwide due to temperature exposure during manufacturing that may have affected product quality and efficacy.

    Product
    Thrombin JMI, Vial 5,000IU 2/diluent, kit, Rx only, MFG: Pfizer NDC 60793-215-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1036-2022·2022-06-15

    FDA Recalls MIOSTAT Carbachol Solution Nationwide for Temperature Abuse

    McKesson Medical-Surgical is recalling MIOSTAT (Carbachol Intraocular Solution) nationwide due to temperature abuse during distribution that may affect medication stability.

    Product
    MIOSTAT — MIOSTAT (CARBACHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1032-2022·2022-06-15

    Doxycycline Capsules Recalled for Temperature Control Deviation

    McKesson Medical-Surgical is recalling Doxycycline Capsules, USP, 100 mg due to temperature abuse during manufacturing. The Class II recall affects 3 bottles distributed nationwide across the USA.

    Product
    DOXYCYCLINE — DOXYCYCLINE (DOXYCYCLINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1048-2022·2022-06-15

    FDA Recalls Metronidazole Vaginal Gel Due to Manufacturing Temperature Abuse

    The FDA is recalling Metronidazole Vaginal Gel USP 0.75% due to temperature abuse during manufacturing. The product was distributed nationwide in the United States.

    Product
    Metronidazole Vaginal Gel USP, 0.75% with 5 applicators, Net Wt. 70 g tube, Rx only, MFG: Sandoz, NDC 0781-7077-87
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1093-2022·2022-06-15

    FDA Recalls Prazosin Hydrochloride Capsules Due to Temperature Storage Deviations

    McKesson is recalling Prazosin Hydrochloride 1 mg capsules distributed nationwide due to temperature deviations during storage that may affect medication stability.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1001-2022·2022-06-15

    Bupivacaine HCl Injection Recalled for Temperature Control Deviation

    McKesson Medical-Surgical is recalling Bupivacaine HCl Injection (0.50%, multi-dose vials, NDC 55150-0250-50) due to cGMP deviations related to temperature abuse during manufacturing. The product was distributed nationwide.

    Product
    Bupivacaine HCl Injection, Multi dose vial, 0.50%, 50 mL/5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0250-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0891-2022·2022-06-01

    Losartan Potassium and Hydrochlorothiazide Tablets Recalled for Elevated Azido Impurity

    Preferred Pharmaceuticals recalls Losartan Potassium & HCTZ Tablets (50mg/12.5mg) in Florida and California due to elevated azido impurity levels above acceptable manufacturing limits.

    Product
    Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0895-2022·2022-06-01

    Blood pressure medication Losartan and hydrochlorothiazide recalled for elevated azido impurity

    Direct Rx recalled Losartan Potassium and Hydrochlorothiazide tablets due to azido impurity levels exceeding acceptable limits. The recall affects 11 bottles distributed in Florida.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0887-2022·2022-06-01

    Losartan HCTZ tablets recalled for manufacturing impurity levels above acceptable limits

    RemedyRepack Inc. is recalling Losartan HCTZ 100/12.5 mg tablets due to elevated AZIDO impurity levels exceeding acceptable manufacturing standards. The recall affects bottles distributed to Florida, South Carolina, and Virginia.

    Product
    Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0872-2022·2022-05-25

    Accupril tablets recalled by Pfizer for nitrosamine impurity

    Pfizer is recalling 2,079 bottles of Accupril (Quinapril HCl) 10 mg tablets due to N-nitrosoquinapril exceeding acceptable limits. The affected lot was distributed nationwide and in Puerto Rico.

    Product
    Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1060-2022·2022-05-18

    First Aid Kits and Cabinets Recalled for Manufacturing Deviations

    Certified Safety Mfg Inc is recalling first aid kits and cabinets containing Medi-First medication components due to manufacturing practice deviations at the component supplier.

    Product
    The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #80450, 2 tablets/packet, 25 packets/box; and Sinus Pain & Pressure, Product #81950, 2 tablets/packet, 25 packets/box. Product number and description: (1) K614-020 16PW - Fir
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Drugs)·D-0833-2022·2022-05-11

    Losartan Potassium Tablets Recalled for Manufacturing Impurity Above Acceptable Limits

    Macleods Pharma USA is recalling Losartan Potassium 50 mg tablets nationwide due to CGMP deviations with AZIDO impurity levels above acceptable limits. Affected lots: BLI2002A, BLI2004A, and BLI2104B.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0835-2022·2022-05-11

    Losartan potassium and hydrochlorothiazide tablets recalled for manufacturing quality deviations

    Macleods Pharma USA is recalling Losartan Potassium and Hydrochlorothiazide tablets due to manufacturing quality issues with chemical impurity levels above acceptable limits. Affected lots were distributed nationwide in 30-, 90-, and 1000-count bottles.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide