The Recall Desk

Hazard

Manufacturing Deviation recalls

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

What the numbers show

Total
296
Critical
0
Severe
7
Most recent
2026-09-09

Of the 296 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 7 (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.

176–200 of 296

  • HighFDA (Drugs)·D-1082-2022·2022-06-15

    Prescription Thrombin Product Recalled for Temperature Storage Deviations

    McKesson is recalling RECOTHROM (Thrombin Topical Recombinant) because products were subjected to temperature abuse during storage or distribution, causing a cGMP (manufacturing practice) deviation.

    Product
    RECOTHROM — RECOTHROM (THROMBIN TOPICAL RECOMBINANT)
    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-1066-2022·2022-06-15

    Clonidine Hydrochloride Tablets Recalled Due to Temperature Abuse During Manufacturing

    FDA recalls 63 bottles of Clonidine Hydrochloride Tablets (0.1 mg, NDC 00228-2127-10) distributed nationwide due to temperature abuse causing cGMP deviations during manufacturing.

    Product
    Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottle, Rx only, MFG: Teva/Actavis, NDC 00228-2127-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1102-2022·2022-06-15

    Prescription eye ointment recalled for temperature storage deviations

    McKesson Medical-Surgical recalls Neomycin and Polymyxin B Sulfates and Dexamethasone ophthalmic ointment (120 tubes) nationwide due to temperature storage deviations during manufacturing.

    Product
    NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE — NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1050-2022·2022-06-15

    FDA Recalls Xylocaine MPF Injectable Due to Temperature Storage Deviations

    McKesson Medical-Surgical is recalling Xylocaine MPF (lidocaine and epinephrine injection) nationwide due to temperature abuse during storage that could affect drug quality. Healthcare providers should discontinue use and contact their supplier.

    Product
    Xylocaine - MPF (lidocaine HCl and epinephrine injection, USP), 1%, 300 mg/30 mL, single dose vial, 5-count box, Rx only, MFG: App Pharmaceuticals LLC, NDC 63323-0487-31
    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-1022-2022·2022-06-15

    Adrenalin epinephrine vials recalled nationwide due to temperature-abuse deviations

    McKesson Medical-Surgical is recalling Adrenalin (epinephrine) 30 mL vials nationwide due to cGMP deviations involving temperature abuse during manufacturing. Temperature excursions may compromise drug potency.

    Product
    ADRENALIN — ADRENALIN (EPINEPHRINE)
    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-1086-2022·2022-06-15

    Gastrografin Prescription Contrast Agent Recalled for Temperature Deviations

    McKesson Medical-Surgical is recalling Gastrografin, a prescription diagnostic contrast agent, due to temperature abuse during manufacturing and distribution. The FDA classified this as a Class II recall.

    Product
    GASTROGRAFIN — GASTROGRAFIN (DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM)
    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-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
  • 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
  • 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-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
  • 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
  • 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