Hetero Labs recalls 40mg Pantoprazole Sodium tablets due to discoloration complaints. This Rx-only medication was manufactured for Camber Pharmaceuticals and may have darker spots or lighter areas.
“Hetero Labs Pantoprazole Tablets Recall: Discoloration Complaints.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/31386-hetero-labs-pantoprazole-tablets-recall-discoloration-complaints. Based on FDA recall #D-0484-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0484-2026%22&limit=1).
The FDA announced on March 26, 2026, that Hetero Labs Limited (Unit V) is recalling Pantoprazole Sodium Delayed-Release Tablets due to discoloration. Owners should contact the manufacturer for a remedy.
The firm received five complaints stating that tablets were discolored darker than normal and had lighter-colored spots. The recall is classified as Class II.
Context
GovInfoNow's records show Hetero Labs Limited (Unit V) has six other recalls on record since December 22, 2017. Other recent recalls of similar products include Sun Pharmaceutical Carbamazepine Tablets Recall: Black Spots From Burnt Ingredients (August 3, 2026), CoValence Laboratories Blemish Spot Treatment 1% Salicylic Acid Recall: Failed Stability (April 1, 2026), and JB Chemicals Recalls Cetirizine Tablets Due to Cross-Contamination (June 24, 2026).
How to tell if you have this one
Check for darker spots or lighter-colored areas on the tablets. The product is a 40mg Pantoprazole Sodium tablet bottle with NDC 31722-713-10, batch #FD253967, and expiration date 06/26/2027.
Brand
Hetero Labs Limited (Unit V)
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Tablets for Discoloration
Look for darker spots or lighter-colored areas on the tablets.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 34 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0484-2026 (March 26, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0484-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.