Cyclobenzaprine Hydrochloride Tablet, Film Coated
FDA Recall NDC 29300-415
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Cyclobenzaprine Hydrochloride (NDC 29300-415). A significant event, classified as Class I, was initiated on Aug 27, 2025 by Unichem Pharmaceuticals (usa), Inc.. The reported reason for this action was: "Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color)."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class I Ongoing
Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
Aug 27, 2025
Sep 24, 2025
230 90-count bottles
Recall Profile & Regulatory Data
Event ID
97482
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Unichem Pharmaceuticals USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the U.S.A
Product Description
Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. NDC 29300-415-19.
Batch or Lot Expiration Information
Lot# Lot No: GMML24026A, Expires: 09/30/2027
Affected Packages Involved in this Recall
29300-413-05Product
29300-413-10Product
29300-413-01Product
29300-413-19Product
29300-414-01Product
29300-414-10Product
29300-415-01Product
29300-415-05Product
29300-415-10Product
29300-415-19Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
