Pantoprazole Sodium recall
FDA recall D-0484-2026 · initiated Mar 26, 2026
Hetero Labs Limited (Unit V) recalled Pantoprazole Sodium in Mar 2026 — an FDA Class II recall (D-0484-2026) because Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots.".
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4,740 1,000-count bottles.
Details
- Product
- Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10
- Recalling company
- Hetero Labs Limited (Unit V)
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA.
- Initiated
- Mar 26, 2026
- FDA report date
- Apr 29, 2026
Frequently asked
- Was Pantoprazole Sodium recalled?
- Hetero Labs Limited (Unit V) recalled Pantoprazole Sodium in Mar 2026 — an FDA Class II recall (D-0484-2026) because Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots.". May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Pantoprazole Sodium recalled?
- Per the FDA enforcement record, the reason for recall D-0484-2026 was: Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
- Is a recalled Pantoprazole Sodium dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Pantoprazole Sodium are affected?
- Distributed: Nationwide in the USA.. The recall covers these lots — Batch # FD253967, Exp Date: 06/26/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0484-2026.