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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Ascend Laboratories Atorvastatin Calcium Tablets Recalled for Failed Dissolution

Agency Publication Date: October 10, 2025
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Summary

Ascend Laboratories, LLC is recalling 141,984 bottles of Atorvastatin Calcium (the generic version of Lipitor) across multiple strengths including 10 mg, 20 mg, 40 mg, and 80 mg. The medication was recalled because it failed dissolution specifications, meaning the tablets may not dissolve properly in the body to release the active medicine. This recall affects various bottle sizes, including 90-count, 500-count, and 1,000-count bottles distributed nationwide across the United States.

Risk

If the tablets do not dissolve as intended, the patient may not receive the full dose of the medication, potentially leading to poorly managed cholesterol levels. No injuries or specific adverse events have been reported to date for this recall.

What You Should Do

  1. Check your medication bottle for Atorvastatin Calcium Tablets USP in strengths of 10 mg, 20 mg, 40 mg, or 80 mg distributed by Ascend Laboratories, LLC.
  2. Verify the lot number and expiration date on the side of the bottle. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Atorvastatin Calcium Tablets USP, 10 mg
Variants: 10 mg, Tablet
Lot Numbers:
25141249 (Exp. Feb. 2027)
24144938 (Exp. Nov. 2026)
24144868 (Exp. Nov. 2026)
24144867 (Exp. Nov. 2026)
24144458 (Exp. Sep. 2026)
24143994 (Exp. Sep. 2026)
24142987 (Exp. July 2026)
24143316 (Exp. July 2026)
NDC:
67877-511-90
67877-511-05
67877-511-10

Manufactured by Alkem Laboratories, Ltd. India; Distributed by Ascend Laboratories, LLC. Affected sizes: 90-count, 500-count, and 1000-count bottles.

Product: Atorvastatin Calcium Tablets USP, 20 mg
Variants: 20 mg, Tablet
Lot Numbers:
25140150 (Exp. Dec. 2026)
25140173 (Exp. Dec. 2026)
25140172 (Exp. Dec. 2026)
24144720 (Exp. Nov. 2026)
24144798 (Exp. Nov. 2026)
24144692 (Exp. Oct. 2026)
24143755 (Exp. Aug. 2026)
24143913 (Exp. Aug. 2026)
24143754 (Exp. Aug. 2026)
24143047 (Exp. June 2026)
24142936 (Exp. July 2026)
NDC:
67877-512-90
67877-512-05
67877-512-10

Manufactured by Alkem Laboratories, Ltd. India; Distributed by Ascend Laboratories, LLC. Affected sizes: 90-count, 500-count, and 1000-count bottles.

Product: Atorvastatin Calcium Tablets USP, 40 mg
Variants: 40 mg, Tablet
Lot Numbers:
25140933 (Exp. Feb. 2027)
25140477 (Exp. Dec. 2026)
24144254 (Exp. Oct. 2026)
24144163 (Exp. Sep. 2026)
24143995 (Exp. Sep. 2026)
NDC:
67877-513-90
67877-513-05
67877-513-10

Manufactured by Alkem Laboratories, Ltd. India; Distributed by Ascend Laboratories, LLC. Affected sizes: 90-count, 500-count, and 1000-count bottles.

Product: Atorvastatin Calcium Tablets USP, 80 mg
Variants: 80 mg, Tablet
Lot Numbers:
25140249 (Exp. Dec. 2026)
25140247 (Exp. Dec. 2026)
24144999 (Exp. Nov. 2026)
24144942 (Exp. Nov. 2026)
24144845 (Exp. Nov. 2026)
24144713 (Exp. Nov. 2026)
24144652 (Exp. Oct. 2026)
24143898 (Exp. Aug. 2026)
24143412 (Exp. Aug. 2026)
24143582 (Exp. Aug. 2026)
NDC:
67877-514-90
67877-514-05

Manufactured by Alkem Laboratories, Ltd. India; Distributed by Ascend Laboratories, LLC. Affected sizes: 90-count and 500-count bottles.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97639
Status: Active
Manufacturer: Ascend Laboratories, LLC
Sold By: Retail pharmacies; Wholesalers
Manufactured In: India
Units Affected: 141,984 bottles
Distributed To: Nationwide
Agency Last Updated: October 14, 2025

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.