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Drug FDA Class II Ongoing Failed specifications

Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

Ascend Laboratories, LLC Published Oct 22, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Ascend Laboratories, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Dissolution Specifications

Hazards

Failed Dissolution · primary

Affected products (1)

Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

ATORVASTATIN CALCIUM

NDC: 67877-511, 67877-512, 67877-513, 67877-514, 67877-511-90, 67877-511-05, 67877-511-10, 67877-511-55, 67877-511-33, 67877-511-38, 67877-512-90, 67877-512-05, 67877-512-10, 67877-512-44, 67877-512-33, 67877-512-38, 67877-513-90, 67877-513-05, 67877-513-10, 67877-513-23, 67877-513-33, 67877-513-38, 67877-514-90, 67877-514-05, 67877-514-10, 67877-514-33, 67877-514-38
Code info: Lot#: 25140933, Exp. Feb. 2027 Lot#: 25140477, Exp. Dec. 2026 Lot#: 24144254, Exp. Oct. 2026 Lot#: 24144163, Exp. Sep. 2026 Lot#: 24143995, Exp. Sep. 2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Sep 19, 2025
  2. Published
    Oct 22, 2025
Recall number
D-0018-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.