Oxytocin USP Powder Recalled Due to Insufficient Stability Data
American Pharmaceutical Ingredients LLC is recalling Oxytocin USP powder because stability data does not support the listed expiration 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, which typically corresponds to a Moderate severity score (2) in the absence of reported injuries or hospitalizations, as the hazard is related to labeling/stability data rather than an immediate physical danger.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Oxytocin USP, powder, 1g-bottle, NDC 58597-7042-3. The recall involves Lot 012517-1R, with a total quantity of 21 g. The product was distributed nationwide in the USA.
The recall was initiated because stability data from the manufacturer does not support the expiration dates listed on the product. This is an FDA Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their supplier for further instructions on return or disposal.
The recalled product
- Product
- Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
- Affected units
- 21
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)
- Lot 012517-1R
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by American Pharmaceutical Ingredients LLC 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.
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