Amitriptyline Hydrochloride Recall: AvKARE 10 mg tablets
Announced 2026-10-28 · FDA
FDA is recalling AvKARE Amitriptyline Hydrochloride 10 mg tablets (Rx only), lot 48489, expiry 12/31/2026, distributed nationwide in the US. The recall is due to failed dissolution specifications. Affected product consists of 3,534 cartons of 50 tablets (5 x 10 unit dose cards in paper cartons), NDC 50268-037-15.
| Brand | AvKARE |
|---|---|
| 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 | Failed dissolution specifications. |
| Severity | moderate |
| Units affected | 3534 |
| Distribution | US Nationwide. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Check if you have this product and locate the lot number on the packaging.
- If you have the recalled product, stop taking it and contact your pharmacist or AvKARE for instructions on disposal or replacement.
- Do not use any recalled tablets and seek guidance from your healthcare provider if you have questions.
How to identify the recalled item
| Lot / date codes | Lot # 48489, Expiry: 12/31/2026 |
|---|---|
| Lot / date codes | Lot # 48489, Expiry: 12/31/2026 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other AvKARE recalls
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.