Pantoprazole (Protonix) recalls

Pantoprazole is a proton pump inhibitor used for acid reflux. We track every FDA enforcement recall involving Pantoprazole (Protonix) — 10 recalls in our database, including 2 active.

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Recent Pantoprazole recalls

Class IIActiveMar 26, 2026
Hetero Labs Limited (Unit V) — Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Recall D-0484-2026
Class IISep 5, 2023
BE PHARMACEUTICALS AG — Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Recall D-1148-2023
Class IIActiveMar 14, 2023
Hetero USA Inc — CGMP Deviations: Discoloration
Recall D-0530-2023
Class IIJul 25, 2022
SUN PHARMACEUTICAL INDUSTRIES INC — Discoloration
Recall D-0068-2023
Class IIApr 11, 2022
Torrent Pharma Inc — CGMP deviations: tablets cracking
Recall D-0852-2022
Class IIMar 15, 2021
Cardinal Health Inc. — CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recall D-0506-2021
Class IIIFeb 5, 2021
SUN PHARMACEUTICAL INDUSTRIES INC — Failed Impurity/Degradation Specifications
Recall D-0251-2021
Class IDec 4, 2017
AuroMedics Pharma LLC — Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
Recall D-0340-2018

Showing 8 of 10. See all Pantoprazole recalls.

What to do if your Pantoprazole is recalled

Don’t panic — and don’t stop taking it on your own. Suddenly stopping a prescription can be riskier than the recall itself.
Check the details. Recalls often affect specific lots, manufacturers, or strengths — not every bottle of Pantoprazole.
Talk to your pharmacist or doctor about whether your supply is affected and what to do next.

This page is for information only and isn’t medical advice. Always follow your clinician’s guidance.

Pantoprazole recall FAQs

How will I know if my Pantoprazole is recalled?

The FDA publishes recalls, but most never make the news. The reliable way is an automated alert: sign up free and we’ll email you when a Pantoprazole recall is issued.

Are generic Pantoprazole recalls common?

Most prescriptions filled in the US are generics, so most recalls involve generic products. A recall doesn’t mean the drug itself is unsafe — it usually affects specific lots or manufacturers.

Is SafeTrack free?

Yes — weekly recall alert digests are free forever, with no credit card required. See pricing.

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