Quality & complianceOfficial

FDA lists Class II recall of American Health Packaging metoclopramide tablets over foreign tablets or capsules

🇺🇸 FDA enforcement report · Wed 21 Oct 2026

The recall, numbered D-0042-2027 and still ongoing, is classified as Class II and covers US nationwide distribution, according to the FDA enforcement report.

The US Food and Drug Administration has recorded a Class II recall of Metoclopramide Tablets from American Health Packaging in its enforcement report dated 21 October 2026. The recall carries the number D-0042-2027.

The stated reason is the presence of foreign tablets or capsules. The entry points to a possible mix-up of other solid dosage forms with the labelled product, but the material available does not describe what the foreign units were or how they got there.

The FDA lists the recall as ongoing, meaning the recalling firm's corrective action had not been closed out at the time of the entry. Distribution is given as US nationwide.

The text supplied for this item contains only the search interface of the FDA enforcement report database. It gives no lot numbers, strengths, pack sizes, expiry dates, quantities or details of the recall's initiation, so these cannot be reported here. Readers need the full database record for that information.

As general context, the FDA assigns Class II to recalls where use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote.

What it means for your team

  • Quality and supply teams handling American Health Packaging metoclopramide should check the full FDA record for affected lots and NDCs, since the summary gives none.
  • Foreign tablet or capsule findings are a recurring packaging and line-clearance concern; sites may wish to review their own mix-up controls.
  • Pharmacovigilance teams may want to watch for any product-quality complaints that mention unexpected tablets in metoclopramide packs.
  • The recall remains ongoing, so its scope or status could change in later enforcement reports.

Official source: FDA enforcement report ↗

Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.

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