Amneal Primidone Tablets Recall Issued
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Amneal Pharmaceuticals is recalling Primidone Tablets, USP, 50 mg due to potential cross-contamination with Acemetacin API.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 27, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, prescription-drug.
What Happened
Amneal Pharmaceuticals, LLC initiated a voluntary recall of Primidone Tablets due to potential cross-contamination with Acemetacin API at the API manufacturer.
Which Products Are Affected
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only. NDC: 53746-544-01. Lot AM251676, EXP 11/31/2028. 27,936 100-count bottles distributed nationwide within the USA. Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, INDIA. Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ.
What You Should Do
The recall was initiated via letter. No additional consumer instructions are provided in the recall notice.
Why This Matters
This is an ongoing Class III recall affecting 27,936 bottles distributed nationwide.
Source
FDA recall number D-0585-2026
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (791 characters here).
Similar severity timing
Same severity (low) notices issued closest in time to July 27, 2026.
Frequently Asked Questions
Common questions about this FDA recall.