Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg,… was recalled on March 26, 2026 in cooperation with the U.S. Food and Drug Administration because discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots.".
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
Batch # FD253967, Exp Date: 06/26/2027
Units affected: 4,740 1,000-count bottles.
Where it was sold: Nationwide in the USA.
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Hetero Labs Limited (Unit V)
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Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
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