FDA Issues Recall for Meclizine Hydrochloride Tablets
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 announced a voluntary recall of specific lots of Meclizine Hydrochloride Tablets due to failed specifications, affecting 697 cartons distributed nationwide.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 7, 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, fda, drugs.
What Happened
The recall was initiated because the tablets failed to meet specifications, as announced by the FDA.
Which Products Are Affected
The affected products are Meclizine Hydrochloride Tablets, USP 12.5 mg, specifically: (a) 50 Tablets [5 x 10] with NDC 60687-775-65, and (b) 12.5 mg Individual Dose with NDC 60687-775-11. A total of 697 cartons are involved, from lot number 1024852 with an expiration date of September 30, 2026. The recall affects products distributed nationwide in the United States.
What You Should Do
Consumers should stop using the affected tablets immediately and contact the recalling firm, Amerisource Health Services LLC, at their address: 2550 John Glenn Ave Ste A, Columbus, OH 43217-1188, for instructions on returns or refunds. The recall was initiated via letter.
Why This Matters
This recall involves a prescription drug that did not meet required standards, potentially posing risks to patient health, and underscores the need for adherence to quality controls in pharmaceuticals.
Source
FDA Recall Number: D-0418-2026. For more information, refer to the FDA's official resources.
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 (1,136 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.