OurPharma Recalls Fentanyl Injection Bags Due to Expiry Date Discrepancy
OurPharma LLC is recalling 1,610 bags of fentanyl citrate injection solution due to a discrepancy between IV bag and product expiry dates.
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 due to a labeling discrepancy regarding expiry dates, which falls under the rubric for minor labeling errors or low-risk contamination without reported injuries.
Plain-English summary
OurPharma LLC is voluntarily recalling 1,610 bags of fentanyl citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag. The recall was initiated after a complaint was received on August 31, 2026, regarding a discrepancy between the IV bag expiry dates (July 31, 2026, and November 30, 2026) and the product expiry date (December 9, 2026).
The affected product is identified by NDC 73013-1013-01, Lot # 101301260605, and a Best Use Date of 12/9/2026. The product was distributed nationwide within the United States.
Healthcare providers and consumers should stop using the affected product and contact OurPharma LLC for further instructions or a refund. The FDA has classified this recall as Class II, indicating that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville, AR, NDC 73013-1013-01.
- Manufacturer
- OurPharma LLC
- Category
- Drug — Injection
- Hazard
- Affected units
- 1,610
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 (2)
- Lot #: 101301260605
- BUD: 12/9/2026.
Distribution
Distributed nationwide across the United States.
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