August 2025 FDA Recall Cyclobenzaprine Hydrochloride by Unichem Pharmaceuticals Usa Inc.
D-0655-2025 - Labeling
This Class I drug recall was voluntarily initiated by Unichem Pharmaceuticals Usa Inc. on August 27, 2025 for the product Cyclobenzaprine Hydrochloride. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0655-2025
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).
08-27-2025
09-24-2025
230 90-count bottles
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Unichem Pharmaceuticals USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the U.S.A
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
