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.

FDA recall notice · announced October 28, 2026 · Avkare

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

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.

Reason for recall

Failed dissolution specifications.

Notes

Distribution: US Nationwide.
Lot/code information: Lot # 48489, Expiry: 12/31/2026
Quantity: 3534 50-count cartons
Status: Ongoing
Products in this recall event:
- 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.

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.