HYDROmorphone Hydrochloride 50 mg Cassettes Recalled for Superpotency
OurPharma LLC is recalling HYDROmorphone Hydrochloride 50 mg/50 mL cassettes nationwide because the assay results showed higher potency than specification.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 an FDA Class III recall. Although the product contains a potent opioid with potential safety implications if dosing is affected, the source text does not report any illnesses, injuries, or patient harm. Class III recalls are by definition unlikely to cause adverse health consequences, supporting a Moderate score.
Plain-English summary
OurPharma LLC is recalling HYDROmorphone Hydrochloride 50 mg/50 mL (1 mg/mL) compounded medication packaged in 50 mL cassettes. The recalled product has NDC 73013-1040-01 and was distributed nationwide. The recall was issued because the assay and potency results for the compounded stability lot were higher than the established specification.
Approximately 1,375 cassettes are affected by this recall. The following lot codes and expiration dates are involved: 104024120001 (Exp Date 06/01/2025), 104024120002 (Exp Date 06/21/2025), 104025010001 (Exp Date 07/13/2025), and 104025010002 (Exp Date 07/28/2025).
Patients currently using this medication should consult their healthcare provider or pharmacist immediately. Healthcare providers and pharmacists should stop dispensing the affected product and contact OurPharma LLC, located at 2512 S. City Lake Rd., Fayetteville, AR 72701, for further instructions on appropriate management and return of the product.
The recalled product
- Product
- HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1040-01.
- Manufacturer
- OurPharma LLC
- Category
- Drug — Opioid / Injectable
- Affected units
- 1,375
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 (8)
- 104024120001
- Exp Date 06/01/2025
- 104024120002
- Exp Date 06/21/2025
- 104025010001
- Exp Date 07/13/2025
- 104025010002
- Exp Date 07/28/2025
Distribution
Distributed nationwide across the United States.
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