Sumatriptan Succinate USP Recalled for Lack of Stability Data
American Pharmaceutical Ingredients LLC is recalling Sumatriptan Succinate USP for prescription compounding due to a lack of stability data supporting the expiration date.
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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a CGMP deviation regarding stability data, which is a quality control issue rather than a direct contamination or acute injury risk, fitting the Moderate severity criteria for minor labeling or quality errors without reported illness.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling 10,000 grams of Sumatriptan Succinate USP for prescription compounding. The product is packed in 25g containers and is available by prescription only. The recall covers Lot #061615-1 with an expiration date of 12/31/2019. The product was distributed nationwide within the USA.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacked the necessary stability data and controls to support the assigned retest or expiration date for the product in its container/closure system.
This recall affects pharmacies and compounding facilities that received the product. Consumers who have this specific lot of Sumatriptan Succinate USP should stop using it and consult their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8633-4.
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
- Affected units
- 10,000
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 #: 061615-1
- Exp.12/31/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 66 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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