Cardinal Health Recalls Pedia-Lax Enemas Due to Temperature Excursions
Cardinal Health is recalling 147 units of Pedia-Lax 66ml enemas due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.
The agency’s classification
FDA (Drugs): 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: The recall is classified as FDA Class II, which corresponds to a moderate severity score. The hazard involves a CGMP deviation (temperature excursion) without reported injuries or illnesses, fitting the criteria for a precautionary recall of a low-risk contamination or labeling issue.
Plain-English summary
Cardinal Health Inc. is recalling 147 units of Pedia-Lax 66ml enemas (NDC/UPC 301320202205). The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage.
The affected lots were distributed between February 23, 2021, and March 10, 2021. Distribution was limited to Florida, Georgia, and South Carolina.
Consumers who have this product should stop using it and contact Cardinal Health Inc. for further instructions or a refund.
The recalled product
- Product
- PEDIA-LAX 66ML; NDC/UPC 301320202205; OTC; ENEMA
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Over-the-Counter (OTC)
- Affected units
- 147
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 (1)
- All Lots distributed 02/23/2021 through 03/10/2021.
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 198 products in this recall →Related recalls
Same manufacturer · Cardinal Health Inc.
See all →- HighEnoxaparin syringe bags recalled after being labeled with the wrong strength
FDA (Drugs) · 2025-09-03
- ModerateXolair auto-injectors 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 75 mg syringes exposed to temperatures outside labeled storage requirements
FDA (Drugs) · 2025-08-13
- ModerateWegovy injection recalled due to temperature exposure during shipping
FDA (Drugs) · 2025-05-07
Same hazard · temperature excursion
See all →- ModerateCyclophosphamide injection vials recalled after a transportation temperature excursion
FDA (Drugs) · 2025-09-24
- ModerateProlia 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
- ModerateEvenity prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
Similar recalls
- HighOptiChamber Diamond Spacer Recalled Due to Temperature Exposure During Shipping
FDA (Devices) · 2021-06-30
- HighOneTouchDelica Lancets Recalled Due to Temperature Exposure During Shipping
FDA (Devices) · 2021-06-30
- HighLithium Carbonate Extended-Release Tablets Recalled for Temperature Excursion
FDA (Drugs) · 2024-01-03
- ModerateChlorthalidone Tablets Recalled for Temperature Storage Deviations
FDA (Drugs) · 2024-01-03
- HighOneTouch Delica Lancets Recalled Due to Temperature Exposure During Shipping
FDA (Devices) · 2021-06-30
- HighCardinal Health Recalls Enteral Infusion Pumps Due to Air Risk
FDA (Devices) · 2021-04-14