Amitriptyline Hydrochloride, Tablets, USP, 10 mg, 5 x 10 Unit dose cards in paper cartons, Rx only, Manufactured for Av
Summary
The FDA issued a Class II for Amitriptyline Hydrochloride, Tablets, USP, 10 mg, 5 x 10 Unit dose cards in pape by AvKARE. Reason: Failed dissolution specifications..
Details
Source
Drug Recall
External ID
32dd4960-0986-4492-91c5-8f39f5c2b40a
Action Date
2026-10-28
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lot # 48489, Expiry: 12/31/2026
Quantity Affected: 3534 50-count cartons
Reason for Recall
Failed dissolution specifications.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-10-02
Company
Pulaski, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 34 drug recalls issued in the same week, part of 76 drug-related FDA actions this month.
AvKARE has 21 FDA actions in our database, including 21 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (AvKARE) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AvKARE have FDA actions?
AvKARE has 21 FDA actions in our database, including 21 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "32dd4960-0986-4492-91c5-8f39f5c2b40a" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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