Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per car...

Published: January 14, 2026Recall ID: D-0292-2026Category: drugsCountry: US

Reason for Recall / Hazard

Out of specification for dissolution.

Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15

Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15

Field	Value
City	Pulaski
State	TN
Openfda › Unii	83MVU38M7Q
Openfda › Route	ORAL
Openfda › Rxcui › 1	859419
Openfda › Rxcui › 2	859747
Openfda › Rxcui › 3	859751
Openfda › Spl id	39ff0f38-7c7a-4ce1-e063-6394a90aa663
Openfda › Brand name	ROSUVASTATIN
Openfda › Spl set id	7cd6ae8d-aa67-60db-e053-2991aa0a0ede
Openfda › Package ndc › 1	50268-709-11
Openfda › Package ndc › 2	50268-709-15
Openfda › Package ndc › 3	50268-710-11
Openfda › Package ndc › 4	50268-710-15
Openfda › Package ndc › 5	50268-711-11
Openfda › Package ndc › 6	50268-711-15
Openfda › Product ndc › 1	50268-709
Openfda › Product ndc › 2	50268-710
Openfda › Product ndc › 3	50268-711
Openfda › Generic name	ROSUVASTATIN
Openfda › Product type	HUMAN PRESCRIPTION DRUG
Openfda › Substance name	ROSUVASTATIN CALCIUM
Openfda › Manufacturer name	AvPAK
Openfda › Application number	ANDA207616
Openfda › Original packager product ndc › 1	31722-883
Openfda › Original packager product ndc › 2	31722-884
Openfda › Original packager product ndc › 3	31722-885
Event id	98246
Address 1	615 N 1st St
Code info	Lot #49124, Exp Date 12/31/2026
Postal code	38478-2403
Report date	20260114
Product type	Drugs
Product quantity	7,991 5x10 cartons
Reason for recall	Out of specification for dissolution.
Voluntary mandated	Voluntary: Firm initiated
Recall initiation date	20251231
Initial firm notification	Letter
Center classification date	20260120