Cardinal Health Recalls Erythromycin Tablets Due to Temperature Excursions
Cardinal Health is recalling Erythromycin Tablets 250mg due to intermittent temperature excursions during storage. The recall affects 135 cartons distributed in Florida, Georgia, and South Carolina.
What this means for you
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 typically corresponds to a moderate severity level where the risk of serious adverse health consequences is remote. The hazard involves temperature excursions, which is a quality control issue rather than a direct contamination or mislabeling of a high-risk allergen.
Plain-English summary
Cardinal Health Inc. is recalling 135 cartons of Erythromycin Tablets, USP 250mg (NDC 69238-1484-3) due to Current Good Manufacturing Practice (CGMP) deviations. The specific issue identified is intermittent exposure to temperature excursions during storage. The affected product is identified by lot code AM200540.
The recalled product was distributed to Florida, Georgia, and South Carolina. This recall is classified as Class II by the U.S. Food and Drug Administration, indicating a situation that might cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers with this product should stop using it and contact their pharmacist or physician for guidance on replacement or disposal. No specific instructions for return or disposal are provided in the source text, so users should follow local regulations or consult their healthcare provider.
The recalled product
- Product
- ERYTHROMYCIN TABLETS, USP 250MG 30; NDC/UPC 69238-1484-3; RX; TABLETS
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Antibiotic
- Affected units
- 135
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)
- AM200540
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