The Recall Desk

Hazard

Out Of Specification recalls

168 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 out of specification 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.

101–125 of 168

  • HighFDA (Devices)·Z-2081-2024·2024-05-29

    Medline Non-Sterile Syringes Recalled Due to Out-of-Specification Manufacturing

    Jiangsu Shenli Medical Production Co., Ltd. is recalling 9,800 Medline non-sterile syringes (model 91852) manufactured in sizes and configurations outside the FDA-cleared range. Customers in six U.S. states should stop using and return the affected product.

    Product
    Brand Name: MEDLINE Product Name: SYR 5ML L/L YELLOW NITRO Model/Catalog Number: 91852 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2060-2024·2024-05-29

    Medline Non-Sterile Syringes Recalled for Out-of-Specification Manufacturing

    Medline brand non-sterile 5mL syringes (Model 91828) are being recalled because the piston syringe sizes and configurations exceed the manufacturer's FDA 510(k) clearance specifications. The recall affects 22,400 units distributed nationwide.

    Product
    Brand Name: MEDLINE Product Name: SYR 5ML L/L WHITE Model/Catalog Number: 91828 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2077-2024·2024-05-29

    MEDLINE Non-Sterile Syringes Recalled Due to Regulatory Non-Compliance

    MEDLINE has recalled 42,000 non-sterile syringes (Model 91847) because their sizes and configurations exceed FDA-approved specifications. The products were distributed nationwide.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE LIDO Model/Catalog Number: 91847 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2072-2024·2024-05-29

    Non-Sterile Syringes Recalled for Manufacturing Beyond FDA-Cleared Scope

    Jiangsu Shenli Medical recalled 3mL non-sterile syringes because they were manufactured outside the scope of FDA approval. The product was distributed nationwide across six U.S. states.

    Product
    Brand Name: MEDLINE Product Name: SYR 3ML L/L PURPLE Model/Catalog Number: 91840 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2043-2024·2024-05-29

    Non-sterile Medline syringes recalled for exceeding FDA clearance specifications

    Medline 30mL non-sterile syringes (Model 83078) are recalled because their designs fall outside the FDA-cleared specifications. About 4.1 million units distributed in the U.S. are affected.

    Product
    Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2086-2024·2024-05-29

    Medline Non-Sterile Syringes Recalled for Non-Compliant Manufacturing Specifications

    Medline non-sterile syringes (Model 91858) are recalled for manufacturing outside FDA-cleared specifications. The recall covers 50,400 units distributed nationwide.

    Product
    Brand Name: MEDLINE Product Name: SYR 20ML L/L WHITE SALINE Model/Catalog Number: 91858 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2096-2024·2024-05-29

    Medline Piston Syringes Recalled for Non-Compliant Manufacturing Specifications

    Jiangsu Shenli Medical is recalling 12,160 Medline piston non-sterile syringes (Model 91878) because manufacturing sizes and configurations exceed FDA 510(k) clearance scope. Distribution was nationwide via U.S. ports.

    Product
    Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L RED Model/Catalog Number: 91878 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2051-2024·2024-05-29

    Non-sterile syringes recalled for manufacturing outside FDA-cleared specifications

    Jiangsu Shenli Medical is recalling 619,200 MEDLINE non-sterile syringes (Model 83087) manufactured in configurations outside FDA-approved specifications. The recall affects units distributed nationwide.

    Product
    Brand Name: MEDLINE Product Name: SYR 20ML L/S Model/Catalog Number: 83087 Product Description: NON-Sterile syringes without needles for single usef Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2102-2024·2024-05-29

    Wolf Medical 3 mL Syringes Recalled for Out-of-Specification Manufacturing

    Jiangsu Shenli Medical is recalling 777,400 Wolf Medical 3 mL syringes (Model SYR03L) manufactured outside FDA clearance scope. Users should discontinue use of affected lot codes.

    Product
    Brand Name: Wolf Medical Product Name: 3 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR03L Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0478-2024·2024-05-08

    Injectable epinephrine-lidocaine recalled for failing potency specification

    Imprimis NJOF, LLC is recalling epinephrine-lidocaine injectables nationwide because they failed to meet potency specifications. Patients should contact their healthcare provider regarding affected lots.

    Product
    Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0430-2024·2024-04-10

    Diltiazem Hydrochloride Capsules Recalled Due to Failed Dissolution Specifications

    Glenmark Pharmaceuticals is recalling 6,528 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide because dissolution testing found the product does not meet specifications. The FDA has classified this as a Class II recall.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0098-2024·2023-11-15

    Oxybutynin Extended-Release Tablets Recalled for Failed Dissolution Test Results

    Zydus Pharmaceuticals is recalling Oxybutynin Extended-Release Tablets (15 mg) after dissolution testing showed out-of-specification results at the 6-month mark. No illnesses have been reported.

    Product
    OXYBUTYNIN — OXYBUTYNIN (OXYBUTYNIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2117-2023·2023-07-19

    Medtronic spinal implant recall due to out-of-specification device dimensions

    Medtronic Catalyft LS Expandable Interbody System spinal implants are being recalled due to out-of-specification device dimensions that may affect proper placement and spinal support.

    Product
    Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2122-2023·2023-07-19

    Medtronic Catalyft LS Spinal Implant Recall for Out-of-Spec Geometry

    Medtronic is recalling Catalyft LS spinal implants due to potential out-of-specification device geometries that may not properly accommodate patient anatomy.

    Product
    Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2121-2023·2023-07-19

    Medtronic Catalyft LS Spinal Implant Recall Due to Out-of-Specification Geometry

    Medtronic recalls 10 units of Catalyft LS spinal implants due to potential out-of-specification device geometries. The affected implants may not properly support or accommodate patient anatomy during lumbar fusion surgery.

    Product
    Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2010-2023·2023-07-05

    Limacorporate Prima TT Orthopedic Baseplate Recalled for Manufacturing Defect

    Limacorporate is recalling 13 units of the Prima TT Genoid Modular Reverse TT Baseplate due to a manufacturing issue that may cause peripheral holes to be out of specification. Healthcare facilities should contact the manufacturer.

    Product
    REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2049-2023·2023-07-05

    LINK Endo-Model Knee Prosthesis Segments Recalled for Out-of-Specification Defects

    The FDA has recalled 13 LINK Endo-Model knee prosthesis femoral segments because they may not meet manufacturing specifications. The defects were discovered through customer complaints.

    Product
    LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Drugs)·D-0539-2023·2023-04-26

    Antipsychotic Drug Recalled for Failed Quality Control Test

    Ascend Laboratories is recalling 135 bottles of Aripiprazole 20 mg tablets nationwide due to failure of spectroscopic identification testing, indicating the product may not meet established quality standards.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0469-2023·2023-03-22

    Eye allergy medication recalled for out-of-specification impurity

    Teva Pharmaceuticals is recalling 715,632 bottles of Clear Eyes Once Daily eye drops due to an out-of-specification impurity found during stability testing.

    Product
    Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL (0.085 fl oz) bottle, Sterile, Distributed by Medtech Products Inc. Tarrytown, NY 10591, A Prestige Consumer Healthcare company, Made in Israel, UPC 67
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0465-2023·2023-03-22

    Buprenorphine Transdermal System Recalled for Failed Impurity Specifications

    AVEVA Drug Delivery Systems recalls nationwide batches of Buprenorphine Transdermal patches due to a degradation impurity exceeding acceptable limits during stability testing.

    Product
    Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7077-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1543-2022·2022-10-05

    FDA Recalls Neoral Cyclosporine for Out-of-Specification Ethanol Content

    Novartis is recalling Neoral cyclosporine 25 mg capsules nationwide due to a manufacturing quality deviation. Lot APCD162 (expiration 01/2023) was found to have out-of-specification ethanol content during stability testing.

    Product
    NEORAL — NEORAL (CYCLOSPORINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0004-2023·2022-10-05

    Esomeprazole Magnesium Capsules Recalled for Out-of-Specification Potency

    Sun Pharmaceutical is recalling Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg nationwide due to superpotency findings. Lot AC14299 (expiration 12/2022) tested out of specification for drug assay at the 12-month stability timepoint.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0992-2022·2022-06-08

    Anagrelide Capsules Recalled Due to Failed Dissolution Specifications

    Teva Pharmaceuticals is recalling Anagrelide Capsules USP 0.5 mg nationwide due to failed dissolution specifications discovered during stability testing. The recall involves lot GD01090 (expired May 2022).

    Product
    Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0970-2022·2022-06-08

    Equate Tartar Control Plus Mouthwash Recalled for Out-of-Specification Formula

    Walmart is recalling Equate Tartar Control Plus mouthwash from certain lots because they were found to have active ingredients outside the approved specification.

    Product
    Equate Tartar Control Plus (Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%) Antiseptic Mouthrise Plus, Antigingivitis/Antiplaque, Blue Mint, 1.5 Liter (50.7 FL OZ) bottle, Distributed By: Wal-Mart Stores, Inc., Bentonville, AR 72716, UPC 6 81131 14800
    Category
    Drug
    Distribution
    Distributed nationwide