FDA Recalls Tramadol Hydrochloride Tablets Over Impurity Issue
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
The FDA has initiated a recall of 29,542 bottles of Tramadol Hydrochloride Tablets due to failed impurities specifications, affecting products distributed nationwide in the USA.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 14, 2026 and geographically references United States. Its severity classification of "medium" 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, cpsc, Drugs.
What Happened
Tramadol Hydrochloride Tablets are being recalled because they failed impurities/degradation specifications, specifically the N-nitroso-desmethyl-tramadol impurity was found out of specification at the 24-month stability interval.
Which Products Are Affected
The affected products are Tramadol Hydrochloride Tablets, USP, 50 mg, in 500-count bottles. The NDC is 60219-2348-5, with other package NDCs including 60219-2348-4, 60219-2348-1, 60219-2348-5, and 60219-2348-7. A total of 29,542 bottles are affected, with lot numbers AM230987 (expiration date 05/2026) and AR232387 (expiration date 12/2026). The recall involves products distributed nationwide within the USA.
What You Should Do
Consumers should contact the recalling firm, Amneal Pharmaceuticals, LLC, at their address: 400 Crossing Blvd Fl 3, Bridgewater, NJ 08807-2863, for instructions regarding the recall, as it is a voluntary firm-initiated action.
Why This Matters
This recall highlights potential quality issues in prescription drugs, which could affect patient safety and the reliability of medications used for pain management.
Source
FDA Recall Notice: Recall Number D-0408-2026, attributed to the FDA.
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 (1,207 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 14, 2026.
Frequently Asked Questions
Common questions about this FDA recall.