⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Ascend Laboratories, LLC: Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem La

DrugsSource: FDA (drug) · Date: 2025-10-22

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Ascend Laboratories, LLC
Product
Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054
Reason / hazard
Failed Dissolution Specifications
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S. Nationwide
Recall initiated
2025-09-19
Code info
Lot#: 25140249, Exp. Dec. 2026 Lot#: 25140247, Exp. Dec. 2026 Lot#: 24144999, Exp. Nov. 2026 Lot#: 24144942, Exp. Nov. 2026 Lot#: 24144845, Exp. Nov. 2026 Lot#: 24144713, Exp. Nov. 2026 Lot#: 24144652, Exp. Oct. 2026 Lot#: 24143898, Exp. Aug. 2026 Lot#: 24143412, Exp. Aug. 2026 Lot#: 24143582, Exp. Aug. 2026
Voluntary mandated
Voluntary: Firm initiated
City
Bedminster
State
NJ
Country
United States
Event id
97639
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