AvKARE recalls amitriptyline hydrochloride tablets 10 mg because they failed dissolution specifications
The amitriptyline hydrochloride tablets, USP, 10 mg, failed dissolution specifications, and the notice covers 3534 50-count cartons sold nationwide in the US.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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.
- Company
- AvKARE
- Hazard
- Failed dissolution specifications.
- Units
- 3534 50-count cartons
- Where sold
- US Nationwide.
- FDA classification
- Class II · Ongoing
- Classified by FDA
- October 26, 2026
- Recall started
- October 2, 2026
- FDA enforcement report
- October 28, 2026
- Identifiers
- Codes: Lot # 48489, Expiry: 12/31/2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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.
- Classification
- Class II (Ongoing)
- Distribution
- US Nationwide.
- Quantity
- 3534 50-count cartons
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