Severity
Low
LowClass IIIOngoing
FDA Drug recall · Reported May 27, 2026
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
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
The recall
Amerisource Health Services LLC issued this low-severity FDA Drug recall — Cross contamination with other products: API contaminated with trace amounts of Acemetacin API..
- Low
- severity level
- Class III
- classification
- May 27, 2026
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0536-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0536-2026) was formally reported on May 27, 2026, with the manufacturer initiating the action on May 1, 2026. It is classified under Low severity (Class III), with a current status of Ongoing. Amerisource Health Services LLC is listed as the recalling firm, operating out of Columbus, OH. Federal records list the affected scope as 63,500 tablets.
The documented reason for this recall is: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Distribution data in the federal record shows the product reached: USA Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category — 14,048 drugs & medications recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified low severity.
Affected scope
63,500 tablets
Related Recalls
6
5 from same agency
Product description
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
Reason for recall
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Ongoing |
| Recall number | D-0536-2026 |
| Date reported | May 27, 2026 |
| Date initiated | May 1, 2026 |
| Recalling firm | Amerisource Health Services LLC |
| Firm location | Columbus, OH |
| Affected scope | 63,500 tablets |
| Distribution | USA Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0536-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Amerisource Health Services LLC. Units affected: 63,500 tablets.
Why was this product recalled? ▼
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 27, 2026. Severity: Low. Recall number: D-0536-2026.
Where was the recalled product distributed? ▼
Distribution: USA Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0536-2026) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Continue exploring
Keep tracking product safety across the federal recall archive.
Recall Checker
Search the full archive by product name, brand, or recall number across every agency.
Check a product →
FDA Drug recalls
Every recall issued by FDA Drug, newest first.
Browse the feed →
RecallRadar
Live feed of the latest recalls across the FDA, CPSC and NHTSA — filter by agency and severity.
View the live feed →
Rankings
The largest recalls by units affected and the most-recalled product categories.
See the rankings →
Browse by category
Find recalls by product type to spot recurring defect patterns.
All categories →
What to do next
A step-by-step guide to refunds, repairs, and returns after a recall.
Read the guide →
Nearby Recalls in This Category
Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
FDA Drug Low
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, …
AVEVA Drug Delivery Systems, Inc. · 2026-06-03
FDA Drug Low
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie c…
AbbVie Inc. · 2026-06-03
FDA Food Moderate
Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement, Net Wt. 8 FL Oz (237mL) Amber PET modern round 24-400 bot…
Llorens Pharmaceuticals International Division, Inc. · 2026-05-27
FDA Drug Moderate
Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by:…
Safecor Health, LLC · 2026-05-27
FDA Drug Moderate
fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3…
IntegraDose Compounding Services LLC · 2026-05-27
Compare this recall with Nicotine Transdermal System Patch, 14 mg, 14 patches per bo… →
Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Drug, reported May 27, 2026.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.