FDA recall,
AvKARE Amitriptyline Hydrochloride Tablets
Amitriptyline Hydrochloride tablets failed dissolution specifications.
Summary by Recall Canary from the FDA notice
What happened
AvKARE is recalling Amitriptyline Hydrochloride, Tablets, USP, 10 mg, 5 x 10 Unit dose cards in paper cartons, Rx only, because the product failed dissolution specifications. The recall began on October 2, 2026, and was added to the FDA's Enforcement Report on October 22, 2026. The product was distributed US Nationwide.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
- NDC
- 50268-037-15
- Lot code
- 48489
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- AvKARE
- Hazard
- Drug dissolving problem
- Event ID
- 100061
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
