FDA Recalls Diphenhydramine HCl Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Diphenhydramine HCl USP f due to a lack of stability data supporting the assigned 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 involves a reasonable probability of temporary or medically reversible health consequences. The hazard is a documentation and stability data deficiency rather than a confirmed contamination or acute injury risk, fitting the Moderate severity criteria for minor labeling or documentation errors.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Diphenhydramine HCl USP f, a prescription compounding ingredient. The product is manufactured by American Pharmaceutical Ingredients LLC and is available in 25g and 100g packages. The specific lots affected are 031715-1, with an expiration date of 12/31/2019.
The recall was initiated because of 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 means the product's quality and safety over time have not been adequately verified.
The product was distributed nationwide within the United States. Because this is a prescription-only product, it is likely held by pharmacies or compounding facilities rather than directly by consumers. Pharmacies and healthcare providers should stop using the affected lots and return them to the manufacturer for credit.
The recalled product
- Product
- Diphenhydramine HCl USP f (or prescription compounding , packaged in a) 25g ( NDC 58597-8081-4); b) 100g (NDC 58597-8081-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
- Affected units
- 8,300
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 (3)
- Lot #: a) 031715-1
- Exp. 12/31/2019
- b) 031715-1
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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