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Teva is pulling 240,448 cartons of a reflux drug after foreign pills turned up in bottles

Teva Pharmaceuticals USA, Inc. is recalling 240,448 cartons of metoclopramide tablets, USP, 5 mg, after the U.S. Food and Drug Administration recorded the reason as the presence of foreign tablets or capsules. Four lots are involved, in bottles of 100 or 500 tablets, and the distribution is nationwide. It reached the public record on October 21, 2026, in the agency’s weekly enforcement report, carrying the middle of the three recall classifications.

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Teva started the recall on September 29, 2026, and FDA classified it on October 13. The status is ongoing.

Four Teva lots and a second company’s cartons

The Teva entry is recall number D-0038-2027 in the October 21 enforcement report, filed under Teva Pharmaceuticals USA of Parsippany, New Jersey. The 100-tablet bottles, NDC 0093-2204-01, come from lots 8634085, 8635085 and 8636085, and the 500-tablet bottles, NDC 0093-2204-05, from lot 8633085. All four carry an expiration of July 2027. The record calls the action voluntary and firm-initiated, with customers told by letter.

The unit of measure deserves care. FDA states the quantity as 240,448 cartons while the product description speaks of bottles of 100 or 500 tablets, and the record does not say how many bottles or tablets a carton holds. The number therefore cannot be converted into a count of bottles or pills. A second company, American Health Packaging of Columbus, Ohio, separately recalled 5,363 cartons of the same 5 mg tablets in 100-count unit-dose packs, recall D-0042-2027, lots 1028135 and 1029555, expiring July 31, 2027, for the same stated reason. The record does not say whether those tablets came from Teva.

Three words of detail: foreign tablets or capsules

The reason line is three words of detail, foreign tablets or capsules, and nothing more. It does not identify the other drug, count how many stray pills turned up, or say where in the supply chain they entered a bottle. A different and earlier Teva action shows how much more some entries say. In 2025, Becker’s Hospital Review reported a voluntary recall of one lot of 10 mg metoclopramide in which three sealed bottles each held a 20 mg torsemide tablet. In that case Teva said a serious reaction was unlikely because pharmacies typically repackage tablets into smaller quantities, and noted the pills looked alike with minor differences in markings and size. The 2026 entry carries no comparable detail, and no individual is named in either account.

FDA’s recall definitions page explains the Class II tier: the probability of serious adverse health consequences is remote, and effects would be temporary or medically reversible. The most serious tier is reserved for a reasonable probability of serious harm or death. A wrong pill in a prescription bottle is still a dispensing error, and a stray tablet of another drug arrives without the label and warnings that belong to it.

The dates follow the same rhythm as the other recalls in the report. Teva started the action on September 29, 2026, FDA assigned the Class II tier on October 13, and the entry was published on October 21 under event number 100013. American Health Packaging began its own action on October 6 and was classified a day later than Teva, on October 14. Both entries carry the same ongoing status, and both were notified to customers by letter, the usual route for a recall that is not aimed at consumers directly.

Who takes 5 mg metoclopramide

The medication guide for Teva’s metoclopramide tablets says the drug relieves heartburn symptoms of gastroesophageal reflux disease, for adults who take it for 4 to 12 weeks when other treatments have failed, and eases slow stomach emptying in people with diabetes. It lists tardive dyskinesia, abnormal muscle movements mostly of the face that may not go away after stopping, as the most important risk, and says the tablets should not be taken for more than 12 weeks. The guide adds that the risk is higher with longer use, higher doses, older age, especially in women, and diabetes, and it tells patients to call a doctor right away about uncontrollable movements such as lip smacking, tongue sticking out or shaking of the arms and legs. The warning dates to a decision announced on February 27, 2009, when Janet Woodcock, then director of FDA’s Center for Drug Evaluation and Research, said chronic use of metoclopramide therapy should be avoided in all but rare cases.

Patients who fill a prescription are least likely to see a carton, since pharmacies repackage bottles, so the lot numbers matter most to pharmacists and distributors checking shelves. The open questions are what the foreign tablets were and how many cartons are still out there, and the entry’s ongoing status means neither answer has been published. openFDA attaches a standing warning to these rows that its data is unvalidated and should not drive medical decisions, which leaves the four lot numbers as the only practical check a pharmacy can run against a bottle already on its shelf.

This article was produced with the assistance of AI and reviewed by Morning Overview editors prior to publication.

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