American Pharmaceutical Ingredients Recalls Gabapentin USP for Prescription Compounding
American Pharmaceutical Ingredients LLC is recalling Gabapentin USP for prescription compounding due to a lack of stability data and controls to support assigned 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. The hazard involves CGMP deviations regarding expiration dates without reported illnesses or injuries, fitting the criteria for a moderate risk.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Gabapentin USP for prescription compounding. The product is available in 25g, 100g, 500g, and 1000g packages and is distributed nationwide within the USA. The recall involves approximately 606,950 units.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm lacked stability data and controls necessary to support the retest or expiration dates assigned to the product in its container/closure system.
Healthcare professionals and patients should discontinue use of the affected lots and return them to the distributor or manufacturer. The specific lot numbers and expiration dates are listed in the structured product information.
The recalled product
- Product
- Gabapentin USP for prescription compounding, packaged in a) 25g (NDC 58597-8014-4); b) 100g (NDC 58597-8014-6); c) 500g (NDC 58597-8014-7); d) 1000g (NDC 58597-8014-8), 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
- 606,950
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 (20)
- Lot #: a) 031116-7
- exp. 03/31/2019
- 112816-1
- Exp. 03/01/2020 b) 011717-2
- 051617-1
- Exp. 04/30/2020
- 031116-1
- 031116-2
- 031116-7
- 051215-1
- exp. 03/05/2018
- 063015-1
- Exp. 05/19/2018
- 092315-1
- Exp. 07/17/2018
- 111615-6
- Exp. 08/27/2018
- Exp. 03/01/2020
- c) 011717-7
- 011717-2
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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