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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98884

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

Open FDA event record

Event summary

Timeline bucket
May 01, 2026
Product types
Drug
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
Amerisource Health Services 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

2 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 2

Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11

D-0536-2026
Recall number
D-0536-2026
Initiated
May 01, 2026
Classification
Class III
Status
Ongoing
Quantity
63,500 tablets

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Code information

Lot#: 1027583, Exp 09/30/2027

Distribution pattern

USA Nationwide

drug · product 2 of 2

Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11

D-0537-2026
Recall number
D-0537-2026
Initiated
May 01, 2026
Classification
Class III
Status
Ongoing
Quantity
225,000 tablets

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Code information

Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027

Distribution pattern

USA Nationwide

Field note

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