FDA recalls Oxytocin product for low potency nationwide
SCA Pharmaceuticals is recalling Oxytocin 30 units in 0.9% Sodium Chloride solution (73,312 containers) nationwide due to subpotency—product contains insufficient active ingredient.
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: FDA Class III recall for a product defect with no reported illnesses or injuries. Per rubric guidelines, Class III recalls are typically scored 1-2, and this subpotency issue presents theoretical rather than documented harm.
Plain-English summary
SCA Pharmaceuticals is recalling Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL (NDC 70004-085-44) due to subpotency. FDA testing determined the product does not meet potency specifications. The recall affects 73,312 single-dose containers distributed nationwide. Affected lot numbers range from 1222043028 through 1223044868, manufactured between April 11, 2023, and July 8, 2023.
No illnesses or injuries have been reported. However, subpotent medication may not produce the intended therapeutic effect, which is particularly significant for a prescription oxytocic used in time-sensitive clinical settings. Healthcare providers should discontinue use of affected lots and contact their supplier or the manufacturer for replacement product.
The recalled product
- Product
- Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- Affected units
- 73,312
Distribution
Distributed nationwide across the United States.
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