Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported July 26, 2023
Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20.
Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Glenmark Therapeutics, Inc. recalled Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark… - a moderate-severity action.
Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark… was recalled by Glenmark Therapeutics, Inc. in July 26, 2023. Reason: Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external la…. Check the official notice for the remedy. Verify recall #D-0939-2023 with the FDA Drug before acting.
The recall
Glenmark Therapeutics, Inc. issued this moderate-severity FDA Drug recall-Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external la….
- Moderate
- severity level
- Class II
- classification
- July 26, 2023
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0939-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0939-2023) was formally reported on July 26, 2023, with the manufacturer initiating the action on May 1, 2023. It is classified under Moderate severity (Class II), with a current status of Terminated. Glenmark Therapeutics, Inc. is listed as the recalling firm, operating out of Mahwah, NJ. Federal records list the affected scope as 19,968 bottles.
The documented reason for this recall is: Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg. 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
19,968 bottles
Related Recalls
6
0 from same agency
Product description
Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20.
Reason for recall
Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0939-2023 |
| Date reported | July 26, 2023 |
| Date initiated | May 1, 2023 |
| Recalling firm | Glenmark Therapeutics, Inc. |
| Firm location | Mahwah, NJ |
| Affected scope | 19,968 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-0939-2023) 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? ▼
Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20.. Recalled by Glenmark Therapeutics, Inc.. Units affected: 19,968 bottles.
Why was this product recalled? ▼
Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 26, 2023. Severity: Moderate. Recall number: D-0939-2023.
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-0939-2023) 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.
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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 July 26, 2023. 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.