October 2026 FDA Recall Amitriptyline Hydrochloride by Avkare
100061 - Failed dissolution specifications.
This Class II drug recall was voluntarily initiated by Avkare on October 2, 2026 for the product Amitriptyline Hydrochloride. The FDA reported the reason for recall as failed dissolution specifications.. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number:
Failed dissolution specifications.
10-02-2026
10-28-2026
3534 50-count cartons
Recall Profile & Regulatory Data
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
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.
AvKARE
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Amitriptyline Hydrochloride, Tablets, USP, 10 mg, 5 x 10 Unit dose cards in paper cartons, Rx only, Manufactured for AvKARE, Pulaski, TN 38478, NDC 50268-037-15.
Batch or Lot Expiration Information
Lot# 48489, Expiry: 12/31/2026
