FDA Recalls Tramadol Hydrochloride Tablets Over Impurity Issue

Source: FDA · United States

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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, cpsc, Drugs) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

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 ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
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.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.