Recall of Pantoprazole Sodium Tablets Due to Discoloration

Source: FDA · United States

Hetero Labs Limited is voluntarily recalling 4,740 bottles of Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, due to complaints about discoloration that may affect the product's quality.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 7, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

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Recall of Pantoprazole Sodium Tablets

What Happened

Hetero Labs Limited initiated a voluntary recall of Pantoprazole Sodium tablets after receiving complaints that the tablets were discolored darker than normal and had lighter-colored spots, which could indicate a quality issue.

Which Products Are Affected

The affected products are Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, in 1,000-count bottles. The National Drug Code (NDC) numbers include 31722-713-10, 31722-712-90, 31722-712-32, 31722-712-31, 31722-713-90, 31722-713-32, and 31722-713-31. The UPC codes are 0331722713900 and 0331722712903. A total of 4,740 1,000-count bottles from Batch # FD253967 with an expiration date of 06/26/2027 are involved. The products were distributed nationwide in the USA.

What You Should Do

Consumers who have the affected Pantoprazole Sodium tablets should contact the recalling firm, Hetero Labs Limited (Unit V), at their address: Unit V, Sy. No.: 439,440,441&458, Tsiic Formulation Sez, Polepally Village, Mahabubnagar, India, for instructions on returns or refunds. This recall is voluntary and firm-initiated.

Why This Matters

This recall involves thousands of bottles of a prescription drug used to treat acid-related disorders, potentially affecting patients who rely on it for their health needs. Ensuring the quality of medications is crucial to prevent any risks associated with ineffective treatment.

Source

This information is from the FDA recall notice, recall number D-0484-2026. For more details, visit the FDA website at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts or search for the recall using the provided details.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Hetero Labs Limited is voluntarily recalling 4,740 bottles of Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, due to complaints about discoloration that may affect the product's quality.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.