Class II · Moderate risk
Pantoprazole Sodium in 0.9% Sodium Chloride Injection
CGMP Deviations
Is Pantoprazole recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Pantoprazole (27 total). Check the affected lots below.
Most common reason: Failed specification (8 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Pantoprazole. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Pantoprazole recalls in 2026
2 initiated in 2026, 27 in total — newest first
Class II · Moderate risk
Pantoprazole Sodium
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Class II · Moderate risk
Pantoprazole Sodium for Injection 40mg per vial
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Class II · Moderate risk
Pantoprazole sodium for Injection 40 mg*/vial
CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Class II · Moderate risk
Pantoprazole Sodium Delayed Release Tablets USP 40mg
CGMP Deviations: Discoloration
Class II · Moderate risk
Pantoprazole 30mg in Ns 7.5ml
Lack of sterility assurance
Class II · Moderate risk
Class II · Moderate risk
Pantoprazole Sodium for Injection
cGMP deviations: Temperature abuse
Class II · Moderate risk
Pantoprazole Sodium Delayed-Release Tablets
CGMP deviations: tablets cracking
Class II · Moderate risk
Pantoprazole Sodium Delayed-Release Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk
Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion…
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Pantoprazole Sodium Delayed-Release Tablets
CGMP Deviations: Presence of dark brown discoloration on edges of tablets
Class II · Moderate risk
Pantoprazole Sodium Delayed Release Tablets
CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
Class II · Moderate risk
Pantoprazole Sodium Delayed-Release Tablets
Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
Class II · Moderate risk
Pantoprazole Sodium Delayed-Release Tablets
Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.
Class I · High risk
Pantoprazole Sodium for Injection
Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
Class III · Low risk
Pantoprazole Sodium for Injection
Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Class III · Low risk
Protonix I.V.
Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
Class II · Moderate risk
Pantoprazole Sodium Delayed-Release Tablets USP
Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of one foreign tablet (Montelukast Sodium Chewable Tab 4mg) in the product bottle of Pantoprazole.
Class II · Moderate risk
Pantoprazole Sodium Monohydrate active pharmaceutical ingredient…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Pantoprazole Sodium
Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets
Class II · Moderate risk
Pantoprazole Sodium Dr
Labeling: Label Mixup: PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabeled as one of the following drugs: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD60272_16, EXP: 5/22/2014; MULTIVITAMIN/MULTIMINERAL, Tablet, 0 mg, NDC 65162066810, Pedigree: AD73646_13, EXP: 5/30/2014.
Class II · Moderate risk
PANTOPRAZOLE SODIUM DR Tablet
Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 40 mg may be potentially mislabeled as SENNOSIDES, Tablet, 8.6 mg, NDC 60258095001, Pedigree: AD37063_17, EXP: 5/13/2014.
Class II · Moderate risk
PANTOPRAZOLE SODIUM DR Tablet
Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 20 mg may be potentially mislabeled as FOSINOPRIL SODIUM, Tablet, 20 mg, NDC 60505251102, Pedigree: AD70690_1, EXP: 5/29/2014.
Class II · Moderate risk
PANTOPRAZOLE SODIUM DR Tablet
Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabeled as DRONEDARONE HCL, Tablet, 400 mg, NDC 00024414260, Pedigree: AD52778_52, EXP: 5/20/2014.
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