The Recall Desk
ModerateFDA (Drugs)·D-0529-2018·Announced 2018-02-28

FDA Recalls Tramadol HCl for Prescription Compounding Due to Stability Data Deficiencies

American Pharmaceutical Ingredients LLC is recalling Tramadol HCl USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.

What this means for you

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 labeling or stability concerns without reported illness.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Tramadol HCl USP (CIV) intended for prescription compounding. The product is packaged in 25g, 100g, 500g, and 1000g containers and is packed by American Pharmaceutical Ingredients, LLC. The recall covers a total of 63,975 grams of the product, which was distributed nationwide within the United States.

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 retest or expiration dates assigned to the product within its container and closure system. This deficiency means the assigned expiration dates may not be valid.

Consumers and healthcare providers who have purchased or received this product should stop using it and contact their pharmacist or the recalling firm for instructions on return or disposal. The product is prescription-only, so it is primarily affected in professional compounding settings.

The recalled product

Product
Tramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC 58597-8032-4); b) 100g (NDC 58597-8032-6); c) 500g (NDC 58597-8032-7); d)1000g (NDC 58597-8032-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Manufacturer
American Pharmaceutical Ingredients LLC
Category
Drug — Pharmaceutical Ingredient
Hazard
Affected units
63,975

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 (14)

  • Lot #: a) UT2140602-1132014
  • Exp. 05/31/2019
  • b) UT2140602-1142014
  • UT2140602-4222015
  • UT2140602-10292014
  • Exp. 05/31/02019
  • UT2131205UI-1192015
  • Exp.11/30/2018
  • c) UT2140602-10282014
  • UT2131205UI
  • Exp. 11/30/2018
  • Exp. 5/31/2019
  • d) UT2140602-10282014
  • Exp. 11/30/2018.

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.

See all 66 products in this recall →

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Same hazard · stability data deficiency

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