The Recall Desk

Hazard

Lack Of Validation recalls

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

What the numbers show

Total
12
Critical
0
Severe
2
Most recent
2023-08-09

Of the 12 lack of validation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (17%) 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 lack of validation 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.

1–12 of 12

  • HighFDA (Drugs)·D-0975-2023·2023-08-09

    FDA Recalls oxyTOCIN IV Bags Over Sterility Assurance Failure

    FDA recalled 751 bags of oxyTOCIN added to Lactated Ringer's IV solution nationwide due to lack of validation data for decontamination cycles, which left sterility assurance unconfirmed.

    Product
    oxyTOCIN 15 units added to Lactated Ringer's 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC:72196-6037-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1048-2023·2023-08-09

    Vecuronium Injection Recalled Due to Lack of Sterility Validation

    Vecuronium injection syringes were recalled nationwide due to lack of validation data for sanitization cycles, which raises sterility assurance concerns.

    Product
    vecuronium, 10 mg/10mL, (1 mg/mL), 10 mL syringe, Rx only, PARALYZING AGENT, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6012-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1498-2019·2019-07-31

    Pharma-Natural Recalls Double Tussin DM Due to Manufacturing Violations

    Pharma-Natural Inc. is recalling 500 bottles of Double Tussin DM because the product was manufactured with current good manufacturing practice violations.

    Product
    DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle, Distributed by: Pamby Dist., Miami, FL 33414, NDC 63708-121-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1507-2019·2019-07-31

    Pharma-Natural Recalls Workvie Pain Roll-On for Manufacturing Violations

    Pharma-Natural Inc. is recalling Workvie Instant Pain Relieving Roll On due to current good manufacturing practice deviations, including lack of process and cleaning validation.

    Product
    Workvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnica), 2.5oz (71 g) roll on bottle, Exclusively Distributed by: Marketite, LLC., Coral Gables, FL 33134, NDC 72393-201-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1495-2019·2019-07-31

    FDA Recalls Oliver's Harvest CBD+Lidocaine Cream for Manufacturing Violations

    Pharma-Natural Inc. is recalling Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief Cream due to current good manufacturing practice violations, including lack of process and cleaning validation.

    Product
    Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pump, Distributed by: Coast to Coast Natural, Inc., Wellington, FL 33414, NDC 63766-119-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1503-2019·2019-07-31

    Pharma-Natural Recalls Dayma Pain Gel for Manufacturing Violations

    Pharma-Natural Inc. is recalling 1,000 jars of Dayma SUPER FORTE XL10 Pain Relieving Topical Analgesic Gel due to current good manufacturing practice violations.

    Product
    Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain Relieving Topical Analgesic Gel, 4 Oz (113.4 g) jar, Distributed by: Biosfera International Distribution, LLC., Miami Lakes, FL 33016, NDC 63788-118-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1494-2019·2019-07-31

    Pharma-Natural Recalls Army Health Pain Reliever Roll-On for CGMP Violations

    Pharma-Natural Inc. is recalling Army Health Pain Reliever Roll-On bottles due to manufacturing process violations. The product was distributed in Florida and Texas.

    Product
    ARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ (73ML) roll on bottle, Manufactured exclusively for: Crossover Telecom, LLC., P.O. Box 520248, Miami, FL 33122, UPC 8 50993 00408 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1505-2019·2019-07-31

    Pharma-Natural Recalls SORBUGEN Cough Syrup Due to Manufacturing Violations

    Pharma-Natural Inc. is recalling 7,392 bottles of SORBUGEN cough syrup because the product was manufactured with current good manufacturing practice violations.

    Product
    SORBUGEN — SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1501-2019·2019-07-31

    Lido E.R. Lidocaine Cream Recalled for Manufacturing Violations

    Pharma-Natural Inc. is recalling Lido E.R. Lidocaine Cream due to current good manufacturing practice violations, including lack of process and cleaning validation.

    Product
    Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz (113 g) jar, Distributed by Diabetic Supply of Suncoast, Inc., P.O. Box 2102, Vega Alta, PR 00692, NDC 63788-115-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1504-2019·2019-07-31

    Pharma-Natural Recalls Tusslin Cough Syrup Due to Manufacturing Violations

    Pharma-Natural Inc. is recalling Tusslin cough syrup because it was manufactured with current good manufacturing practice violations, including a lack of process validation.

    Product
    TUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl, 10 mg) in each 5 mL tsp, Grape Flavor, 16 Fl.oz. (474 mL) bottle, Kramer Novis, San Juan, PR 00917, NDC 52083-622-16.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1493-2019·2019-07-31

    Pharma-Natural Recalls AbeeMed Cream Due to Manufacturing Violations

    Pharma-Natural Inc. is recalling AbeeMed cream because it was manufactured with current good manufacturing practice violations, including a lack of process and cleaning validation.

    Product
    AbeeMed cream (Menthol 1.48% and Histamine DHCL 0.05%), 2 OZ jar, Manufactured exclusively for: Cas, P.O. Box 520248, Miami, FL 33152, UPC 8 50993 00402 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1136-2013·2013-04-24

    EndoGastric Solutions Recalls EsophyX2 Plus Devices Due to Lack of Validation

    EndoGastric Solutions is recalling 190 EsophyX2 Plus devices used to treat GERD because they were not validated under actual or simulated use conditions before distribution.

    Product
    EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in part "EsophyX2 2-LINK Device Qty: (1) Fastener Delivery System ***" Designed for the treatment of Gastroesophageal Reflux Disease (GERD), with erosive and no
    Category
    Medical Device
    Distribution
    Distributed nationwide