American Health Packaging Metoclopramide 5 mg Recall D-0042-2027

American Health Packaging initiated a voluntary recall of Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, because of the presence of foreign tablets or capsules. The FDA assigned recall number D-0042-2027 and classified it Class II. The recall covers 5,363 cartons and is listed as Ongoing in the FDA enforcement record.

At a glance

• The recalling firm is American Health Packaging of 2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188.
• The product is Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, with NDC carton 60687-620-01 and NDC unit dose 60687-620-11.
• The firm initiated the recall on October 6, 2026, the FDA classified it on October 14, 2026, and the FDA published the record on October 21, 2026.
• The reason given in the FDA record is “Presence of Foreign Tablets/Capsules,” and the recall quantity is 5,363 cartons.
• The FDA describes the action as “Voluntary: Firm initiated,” with a distribution pattern of “US Nationwide.”

What the FDA enforcement record shows

The FDA enforcement record for D-0042-2027 lists the action as a Class II recall. The FDA’s drug recall page explains that a recall is a voluntary action taken by a company to remove a defective drug from the market or to warn patients and consumers about a potential risk. The same page states that recalls not marked as terminated are either ongoing or completed.

The record identifies the affected lots as Lot 1028135 and Lot 1029555, both with an expiration date of 07/31/2027. The product is described as an oral, human prescription drug, and the openFDA fields list the active substance as metoclopramide hydrochloride.

The record links the product to abbreviated new drug application ANDA072801 and lists product NDCs 60687-620 and 60687-631, with package NDCs 60687-620-11, 60687-620-01, 60687-631-11 and 60687-631-01. The record also lists original packager product NDCs 0093-2204 and 0093-2203.

What is established vs. what is alleged

Established in the FDA record: a recall exists under number D-0042-2027, it names American Health Packaging as the recalling firm, it covers 5,363 cartons of the 5 mg product, and the stated reason is the presence of foreign tablets or capsules. These are regulatory record entries, not court findings.

Alleged or not yet determined: the record does not state how the foreign tablets or capsules entered the product, when the problem began, whether any injury occurred, or whether any product reached a patient. The reason for recall field is the firm’s stated reason as published by the FDA, and the Class II designation is an FDA classification, not a judicial determination of fault.

Where the claims stand procedurally

No federal consolidation exists for claims about this recall. There is no multidistrict litigation (MDL, a procedure that groups related federal cases before one judge) and no Judicial Panel on Multidistrict Litigation (JPML, the body that decides whether to create an MDL) transfer order in the supplied sources. Any legal claims arising from the recall would be filed individually unless a court or the JPML later acts, and the supplied documents show no such filing.

Unlike consolidated matters such as the sartan recalls litigation or the Zantac ranitidine litigation, this recall record is a single FDA enforcement entry with no accompanying case docket. The status of a recall and the status of litigation are separate, and this record speaks only to the former.

Key dates

• October 6, 2026: American Health Packaging initiated the voluntary recall (recall_initiation_date 20261006).
• October 14, 2026: the FDA assigned the Class II classification (center_classification_date 20261014).
• October 21, 2026: the FDA published the enforcement record (report_date 20261021).
• July 31, 2027: expiration date listed for Lots 1028135 and 1029555.
• As of the openFDA last_updated date of October 21, 2026, the recall status is Ongoing.

What this does not establish

The record does not establish that any patient was harmed, that any carton reached a pharmacy or a patient, or that any recall was incomplete or ineffective. It does not establish liability, negligence or a violation of law by any party.

The record also does not state the identity of the foreign tablets or capsules, the number of affected units within the cartons, or whether a market withdrawal or public warning accompanied the recall. The FDA’s disclaimer on openFDA data states that the data should be treated as unvalidated and not relied on for medical decisions.

How an FDA drug recall is classified

The FDA assigns a recall classification after reviewing the firm’s action and the hazard presented. The agency’s drug recall page describes a recall as a company’s voluntary removal of a defective drug or a warning about a potential risk, and it notes that terminated recalls are those where the FDA has determined all reasonable efforts were made to remove or correct the product.

Class II, the classification used here, appears in the enforcement record without further explanation of the hazard scale. The FDA publishes recall announcements by company on its drug recalls page, where entries appear with a date, brand name, product description, recall reason and company name.

Frequently asked questions

What product does FDA recall D-0042-2027 cover?

FDA recall D-0042-2027 covers Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, distributed by American Health Packaging of Columbus, Ohio. The carton NDC is 60687-620-01 and the unit dose NDC is 60687-620-11. The FDA record lists 5,363 cartons under the recall.

Why did American Health Packaging recall the metoclopramide tablets?

The FDA enforcement record states the reason for recall as “Presence of Foreign Tablets/Capsules.” The record does not identify the foreign material or explain how it entered the product. The FDA classified the action as Class II.

Which lots of metoclopramide are affected?

The affected lots are Lot 1028135 and Lot 1029555, both listed with an expiration date of 07/31/2027. Those lot numbers appear in the code_info field of the FDA enforcement record for D-0042-2027. The record does not describe how cartons from these lots should be handled.

Is the metoclopramide recall part of a lawsuit or MDL?

No federal consolidation exists for claims about the D-0042-2027 recall in the supplied sources. There is no MDL number and no JPML transfer order connected to this recall. The FDA enforcement record is a regulatory entry and does not itself create or describe any court case.

When did the FDA publish the American Health Packaging recall?

American Health Packaging initiated the recall on October 6, 2026, and the FDA classified it on October 14, 2026. The FDA published the enforcement record on October 21, 2026. As of the openFDA last_updated date of October 21, 2026, the recall status reads Ongoing.

Sources

1. U.S. Food and Drug Administration (openFDA): “Drug Enforcement Report D-0042-2027” (link, accessed 2026-10-30)
2. U.S. Food and Drug Administration: “Drug Recalls” (link, accessed 2026-10-30)
3. U.S. Food and Drug Administration: “Drug Safety Communications” (link, accessed 2026-10-30)
4. U.S. Food and Drug Administration: “Drugs@FDA Data Files” (link, accessed 2026-10-30)
5. U.S. Food and Drug Administration: “What’s New: Drugs RSS Feed” (link, accessed 2026-10-30)
6. U.S. Food and Drug Administration: “Drug Safety and Availability” (link, accessed 2026-10-30)