Recall archive / FDA company announcement

CAPS: Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag — FDA announcement Feb 25, 2025

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Feb 25, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag
Reason: Due to visible black particulate matter
Classification: Not supplied
Recalling firm: CAPS
Quantity: Not supplied
Agency-reported status: Company recall announcement
Source record identifier: bd42b3c8824a1a1a

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	CAPS drug product is packaged in 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag. The product can be identified by the sample label below, the NDC format for products compounded at Lehigh Valley is “71285-XXXX-X.” The lot number format is “37-XXXXXX.”; NDC \| Product Description \| Lot # \| Expiration Date \| Distribution Dates \| Region Distributed; 71285-6092-1 \| Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag \| 37-928390 \| 03MAR2025 \| 17 Dec 2024 \| United States; 71285-6092-1 \| Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag \| 37-928796 \| 09MAR2025 \| 26 Dec 2024 \| United States; 71285-6092-1 \| Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag \| 37-928839 \| 10MAR2025 \| 03 Jan 2025 – 08 Jan 2025 \| United States

Label field

Details supplied by the agency

Lot, code or applicability

CAPS drug product is packaged in 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag. The product can be identified by the sample label below, the NDC format for products compounded at Lehigh Valley is “71285-XXXX-X.” The lot number format is “37-XXXXXX.”; NDC | Product Description | Lot # | Expiration Date | Distribution Dates | Region Distributed; 71285-6092-1 | Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag | 37-928390 | 03MAR2025 | 17 Dec 2024 | United States; 71285-6092-1 | Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag | 37-928796 | 09MAR2025 | 26 Dec 2024 | United States; 71285-6092-1 | Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag | 37-928839 | 10MAR2025 | 03 Jan 2025 – 08 Jan 2025 | United States

Match all identifying details in the current notice. A brand name alone is not enough.

Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

FDA company announcement, table 1
NDC	Product Description	Lot #	Expiration Date	Distribution Dates	Region Distributed
71285-6092-1	Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag	37-928390	03MAR2025	17 Dec 2024	United States
71285-6092-1	Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag	37-928796	09MAR2025	26 Dec 2024	United States
71285-6092-1	Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag	37-928839	10MAR2025	03 Jan 2025 – 08 Jan 2025	United States

Announcement retrieved Oct 1, 2026. Official announcement.

Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Fda listing date: Feb 25, 2025
Company announcement date: Feb 24, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.