Severity
Low
LowClass IIIOngoing
FDA Drug recall · Reported June 17, 2026
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Amneal Pharmaceuticals, LLC recalled Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal P… - a low-severity action.
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal P… was recalled by Amneal Pharmaceuticals, LLC in June 17, 2026. Reason: Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due t…. Check the official notice for the remedy. Verify recall #D-0585-2026 with the FDA Drug before acting.
The recall
Amneal Pharmaceuticals, LLC issued this low-severity FDA Drug recall-Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due t….
- Low
- severity level
- Class III
- classification
- June 17, 2026
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0585-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0585-2026) was formally reported on June 17, 2026, with the manufacturer initiating the action on June 3, 2026. It is classified under Low severity (Class III), with a current status of Ongoing. Amneal Pharmaceuticals, LLC is listed as the recalling firm, operating out of Bridgewater, NJ. Federal records list the affected scope as 27,936 100-count bottles.
The documented reason for this recall is: Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer. Distribution data in the federal record shows the product reached: Nationwide within the USA.. 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 - 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.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,772 children & baby products recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
27,936 100-count bottles
Related Recalls
6
0 from same agency
Product description
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01
Reason for recall
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Ongoing |
| Recall number | D-0585-2026 |
| Date reported | June 17, 2026 |
| Date initiated | June 3, 2026 |
| Recalling firm | Amneal Pharmaceuticals, LLC |
| Firm location | Bridgewater, NJ |
| Affected scope | 27,936 100-count bottles |
| Distribution | Nationwide within the USA. |
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-0585-2026) 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, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01. Recalled by Amneal Pharmaceuticals, LLC. Units affected: 27,936 100-count bottles.
Why was this product recalled? ▼
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 17, 2026. Severity: Low. Recall number: D-0585-2026.
Where was the recalled product distributed? ▼
Distribution: Nationwide within the USA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0585-2026) 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.
Nationwide recalls with similar severity or category timing
Two federal-filing-derived peer sets for this notice, both outside the same recalling firm and filing state so the neighborhoods are not firm or geographic containment.
Similar severity · nearest report date
Same archive severity grade (Low), closest by report date among other firms and states.
Similar Children & Baby Products · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported June 17, 2026. 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 August 2026.