Dynarex DynaLube Lubricating Jelly Recalled Due to Temperature Excursions
Mckesson is recalling Dynarex DynaLube lubricating jelly due to facility temperature excursions from June-August 2021 that may have degraded product effectiveness. Recall affects 17.5 boxes distributed nationwide between June-September 2021.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II FDA medical device recall initiated as a precautionary measure due to theoretical impacts on product effectiveness from heat exposure. No reported illnesses, injuries, or confirmed harm, and the recall is characterized as a protective precautionary action.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling Dynarex DynaLube lubricating jelly (Catalog #1250, 2.7 gram packets) because the product was exposed to higher than intended temperatures at the facility between June and August 2021 prior to shipment. This heat exposure may have impacted product effectiveness.
The recall affects approximately 17.5 boxes that were distributed nationwide and received between June 1, 2021 and September 30, 2021. Affected products can be identified by their GTIN codes: 00616784125039, 00616784125015, and 00616784125022.
Consumers or healthcare facilities who received affected products should contact their medical supplier or Mckesson Medical-Surgical Inc. for guidance on replacement products.
The recalled product
- Product
- DYNAREX DynaLube LUBRICATING JELLY, STR 2.7GM (144/BX 12BX/CS) Catalog #1250
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- GTIN: 00616784125039
- 00616784125015
- '00616784125022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 55 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 55 products in this recall →Related recalls
Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office
See all →- ModerateStrep A test kits recalled after shipment to unlicensed purchasing customers
FDA (Devices) · 2025-08-27
- ModerateProlia prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateEvenity prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateBenlysta vials recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateAbbott Diagnostics ARC Carbon Dioxide Calibrator Cold Chain Storage Issue
FDA (Devices) · 2025-06-04
Same hazard · temperature excursion
See all →- ModerateCyclophosphamide injection vials recalled after a transportation temperature excursion
FDA (Drugs) · 2025-09-24
- ModerateXolair 75 mg syringes exposed to temperatures outside labeled storage requirements
FDA (Drugs) · 2025-08-13
- ModerateRecombinate antihemophilic factor vials exposed to temperatures outside labeled storage
FDA (Drugs) · 2025-08-13
- ModerateXolair auto-injectors exposed to temperatures outside labeled storage requirements
FDA (Drugs) · 2025-08-13
Similar recalls
- ModeratePetrolatum Jelly Recalled Due to Temperature Exposure Prior to Delivery
FDA (Devices) · 2022-10-05
- ModerateDynarex Unna Boot Dressing products recalled due to temperature storage excursion
FDA (Devices) · 2022-10-05
- ModerateDynarex Wet Wipes Recalled Due to Facility Temperature Exposure
FDA (Devices) · 2022-10-05
- ModerateCollagen Powder Recalled Due to Temperature Exposure During Shipment
FDA (Devices) · 2022-10-05
- ModerateMcKesson Absorbent Dressings Recalled Due to Temperature Storage Excursions
FDA (Devices) · 2022-10-05
- HighFirmagon Degarelix Injection Recalled for Temperature Abuse During Distribution
FDA (Drugs) · 2022-06-15