Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0481-2018·Announced 2018-02-28

Cyclobenzaprine HCl USP Recalled for Lack of Stability Data

American Pharmaceutical Ingredients LLC is recalling Cyclobenzaprine HCl USP for prescription compounding due to a lack of stability data supporting 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 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 safety defect.

Plain-English summary

American Pharmaceutical Ingredients LLC is recalling Cyclobenzaprine HCl USP for prescription compounding. The product is available in 25g, 100g, 500g, and 1000g packages and is intended for prescription use only. The recall covers a total quantity of 123,900 grams of the product.

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 dates for the product in its container/closure system. The affected lots include various expiration dates ranging from 2018 to 2020.

The product was distributed nationwide within the United States. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product: Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8011-4), b)100g (NDC 58597-8011-6); c) 500 g (NDC 58597-8011-7); d)1000g (NDC 58597-8011-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Manufacturer: American Pharmaceutical Ingredients LLC
Category: Drug — Pharmaceutical Ingredient
Hazard: cgmp-deviation
stability-data
Affected units: 123,900

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 (12)

Lot #: a) 081715-1
Exp. 2/29/2020
b) 010615-1
Exp. 6/30/2019
051616-1
Exp.11/30/2020
081715-1
CBP1307004BVP-4102015
Exp. 4/30/2018
c) 010615-1
Exp. 2/29/2020 d) 010615-1
081715-2

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.

See all 66 products in this recall →

Same manufacturer · American Pharmaceutical Ingredients LLC

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Same hazard · cgmp deviation