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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97639

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 19, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Ascend Laboratories, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 4

Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

D-0017-2026
Recall number
D-0017-2026
Initiated
September 19, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Ascend Laboratories, LLC
Quantity
141,984 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Dissolution Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications

Code information

Lot#: 25141249, Exp. Feb. 2027 Lot#: 24144938, Exp. Nov. 2026 Lot#: 24144868, Exp. Nov. 2026 Lot#: 24144867, Exp. Nov. 2026 Lot#: 24144458, Exp. Sep. 2026 Lot#: 24143994, Exp. Sep. 2026 Lot#: 24142987, Exp. July 2026 Lot#: 24143316, Exp. July 2026

Distribution pattern

U.S. Nationwide

drug · product 2 of 4

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.

D-0018-2026
Recall number
D-0018-2026
Initiated
September 19, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Ascend Laboratories, LLC
Quantity
Unavailable

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Dissolution Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications

Code information

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

Distribution pattern

U.S. Nationwide

drug · product 3 of 4

Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

D-0019-2026
Recall number
D-0019-2026
Initiated
September 19, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Ascend Laboratories, LLC
Quantity
Unavailable

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Dissolution Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications

Code information

Lot #: 25140150, Exp. Dec. 2026 Lot #: 25140173, Exp. Dec. 2026 Lot #: 25140172, Exp. Dec. 2026 Lot #: 24144720, Exp. Nov. 2026 Lot #: 24144798, Exp. Nov. 2026 Lot #: 24144692, Exp. Oct. 2026 Lot #: 24143755, Exp. Aug. 2026 Lot #: 24143913, Exp. Aug. 2026 Lot #: 24143754, Exp. Aug. 2026 Lot #: 24143047, Exp. June 2026 Lot #: 24142936, Exp. July 2026

Distribution pattern

U.S. Nationwide

drug · product 4 of 4

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

D-0020-2026
Recall number
D-0020-2026
Initiated
September 19, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Ascend Laboratories, LLC
Quantity
Unavailable

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Dissolution Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications

Code information

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

Distribution pattern

U.S. Nationwide