Severity
Moderate
ModerateClass IIOngoing
FDA Drug recall · Reported April 29, 2026
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
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Hetero Labs Limited (Unit V) recalled Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Man… - a moderate-severity action.
Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Man… was recalled by Hetero Labs Limited (Unit V) in April 29, 2026. Reason: Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and hav…. Check the official notice for the remedy. Verify recall #D-0484-2026 with the FDA Drug before acting.
The recall
Hetero Labs Limited (Unit V) issued this moderate-severity FDA Drug recall-Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and hav….
- Moderate
- severity level
- Class II
- classification
- April 29, 2026
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0484-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0484-2026) was formally reported on April 29, 2026, with the manufacturer initiating the action on March 26, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Hetero Labs Limited (Unit V) is listed as the recalling firm, operating out of Mahabubnagar, N/A. Federal records list the affected scope as 4,740 1,000-count bottles..
The documented reason for this recall is: Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots." Distribution data in the federal record shows the product reached: Nationwide in the USA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
4,740 1,000-count bottles.
Related Recalls
6
0 from same agency
Product description
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
Reason for recall
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0484-2026 |
| Date reported | April 29, 2026 |
| Date initiated | March 26, 2026 |
| Recalling firm | Hetero Labs Limited (Unit V) |
| Firm location | Mahabubnagar, N/A |
| Affected scope | 4,740 1,000-count bottles. |
| Distribution | Nationwide in the USA. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0484-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Hetero Labs Limited (Unit V). Units affected: 4,740 1,000-count bottles..
Why was this product recalled? ▼
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 29, 2026. Severity: Moderate. Recall number: D-0484-2026.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0484-2026) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported April 29, 2026. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.