AvKARE amitriptyline tablets recalled for failed dissolution
AvKARE is recalling one lot of amitriptyline hydrochloride 10 mg tablets because they failed dissolution specifications. The recall covers 3,534 cartons of 50-count unit dose cards distributed nationwide. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All AvKARE recalls
What to do
- Talk to your pharmacist or prescriber before stopping it.
- Check the carton for lot 48489, expiration date 12/31/2026, and NDC 50268-037-15.
- The notice doesn't say how to get a refund or replacement; ask AvKARE or where you bought it.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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.
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- 3534 50-count cartons
- Illnesses reported
- None reported
- Manufactured in
- 615 N 1st St, Pulaski, TN, United States
- Classification
- Class II
- Recall number
- 100061
In the FDA's words
- 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. Failed dissolution specifications. Lot # 48489, Expiry: 12/31/2026 Distribution: US Nationwide. Affected quantity: 3534 50-count cartons
- Hazard
- Failed dissolution specifications.
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ModerateFDAOct 30, 2026