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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95768

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

Open FDA event record

Event summary

Timeline bucket
November 18, 2024
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Viatris Inc

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

11 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 11

Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

D-0118-2025
Recall number
D-0118-2025
Initiated
November 18, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Viatris Inc
Quantity
92,512 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug and Subpotent Drug: potency failures obtained

Code information

Lot #: a) 3182797, Exp. Date Nov 2024; 8177587, b) 3199816, Exp. Date Jun 2025

Distribution pattern

Nationwide within the United States and Puerto Rico

drug · product 2 of 11

Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles (NDC 0378-1823-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

D-0119-2025
Recall number
D-0119-2025
Initiated
November 18, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Viatris Inc
Quantity
118,324 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug and Subpotent Drug: potency failures obtained

Code information

Lot #: a) 8165919, Exp. Date Dec 2024; 8172050, Exp. Date Mar 2025; 8183251, Exp. Date Sept 2025 b) 3185542, Exp. date Dec 2024; 3192838, Exp. Date Mar 2025; 3208172, Exp. Date Sept 2025

Distribution pattern

Nationwide within the United States and Puerto Rico

drug · product 3 of 11

Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

D-0120-2025
Recall number
D-0120-2025
Initiated
November 18, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Viatris Inc
Quantity
9,828 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug and Subpotent Drug: potency failures obtained

Code information

Lot #: a) 8177720, Exp. Date Jun 2025; b) 3200218, Exp. Date Jun 2025

Distribution pattern

Nationwide within the United States and Puerto Rico

drug · product 4 of 11

Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles (NDC 0378-1817-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

D-0121-2025
Recall number
D-0121-2025
Initiated
November 18, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Viatris Inc
Quantity
19, 549 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug and Subpotent Drug: potency failures obtained

Code information

Lot #: a) 3192915, 8172108, Exp. Date Mar 2025; b) 3208680, Exp. Date Sep 2025

Distribution pattern

Nationwide within the United States and Puerto Rico

drug · product 5 of 11

Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles (NDC 0378-1819-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

D-0122-2025
Recall number
D-0122-2025
Initiated
November 18, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Viatris Inc
Quantity
55,032 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug and Subpotent Drug: potency failures obtained

Code information

Lot #: a)8179847, Exp. Date July 2025; b) 3203518, Exp. Date July 2025

Distribution pattern

Nationwide within the United States and Puerto Rico

drug · product 6 of 11

Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and b) 1000-count bottles (NDC 0378-1800-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

D-0123-2025
Recall number
D-0123-2025
Initiated
November 18, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Viatris Inc
Quantity
34,845 bottes

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug and Subpotent Drug: potency failures obtained

Code information

Lot #: a) 8181875, Exp. Date Aug 2025; 8174497, Exp. Date April 2025 b) 3209099, Exp. Date Sep 2025; 3206534, Exp. Date Aug 2025; 3196137, Exp. Date April 2025

Distribution pattern

Nationwide within the United States and Puerto Rico

drug · product 7 of 11

Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC 0378-1803-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

D-0124-2025
Recall number
D-0124-2025
Initiated
November 18, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Viatris Inc
Quantity
42,331 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug and Subpotent Drug: potency failures obtained

Code information

Lot #: a) 8174701, Exp. Date April 2025; 8182228, Exp. Date Aug 2025 b)3193984, Exp. Date Mar 2025; 3206790, Exp. Date Aug 2025

Distribution pattern

Nationwide within the United States and Puerto Rico

drug · product 8 of 11

Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC 0378-1805-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

D-0125-2025
Recall number
D-0125-2025
Initiated
November 18, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Viatris Inc
Quantity
63,077 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug and Subpotent Drug: potency failures obtained

Code information

Lot #: a) 8177078, Exp. Date May 2025; 8168596, Exp. Date Jan 2025 b) 3199313, Exp. Date May 2025; 3194118, Exp. Date Mar 2025; 3186238, Exp. Date Dec 2024; 3209590, Exp. Date Sep 2025; 3199317, Exp. Date May 2025; 3188733, Exp. Date Jan 2025

Distribution pattern

Nationwide within the United States and Puerto Rico

drug · product 9 of 11

Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (NDC 0378-1807-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

D-0126-2025
Recall number
D-0126-2025
Initiated
November 18, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Viatris Inc
Quantity
43,765 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug and Subpotent Drug: potency failures obtained

Code information

Lot # a) 8180781, Exp. Date Aug 2025; b)3191628, Exp. Date Feb 2025; 3197139, Exp. Date Apr 2025; 3188976, Exp. Date Jan 2025; 3184929, Exp. Date Dec 2024; 3204909, Exp. Date Aug 2025

Distribution pattern

Nationwide within the United States and Puerto Rico

drug · product 10 of 11

Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

D-0127-2025
Recall number
D-0127-2025
Initiated
November 18, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Viatris Inc
Quantity
65,169

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug and Subpotent Drug: potency failures obtained

Code information

Lot #: a) 8171269, Exp. Date Feb 2025; 8179579, Exp. Date July 2025 b)3183815, Exp. Date Nov 2024; 3189147, Exp. Date Jan 2025; 3192027, Exp. Date Feb 2025; 3202894, Exp. Date Jul 2025; 3192026, Exp. Date Feb 2025; 3199781, Exp. Date Jun 2025. 3192028, exp. date Feb 2025 3202895, exp. date July 2025

Distribution pattern

Nationwide within the United States and Puerto Rico

drug · product 11 of 11

Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

D-0128-2025
Recall number
D-0128-2025
Initiated
November 18, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Viatris Inc
Quantity
35,883 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug and Subpotent Drug: potency failures obtained

Code information

Lot #: a) 8171623, Exp. Date Feb 2025; 8164486, Exp. Date Nov 2024 b)3205462, Exp. Date Aug 2025; 3192428, Exp. Date Feb 2025; 3184096, Exp. Date Nov 2024

Distribution pattern

Nationwide within the United States and Puerto Rico