PlainRecalls
LowClass IIITerminated

FDA Drug recall · Reported August 30, 2017

Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-791-14), c) 21-count bottle (NDC 55289-791-21), d) 30-count bottle (NDC 55289-791-30), e) 60-count bottle (NDC 55289-791-60), Packaged by PD-Rx Pharmaceuticals, Incorporated, Oklahoma City, OK. 73127 Mfg: KVK-Tech, Inc. Newtown, PA 18940

Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .

Recall #
D-1118-2017
Affected scope
3440 bottles
Initiated
August 11, 2017
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
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PD-Rx Pharmaceuticals, Inc. recalled Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( … - a low-severity action.

Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( … was recalled by PD-Rx Pharmaceuticals, Inc. in August 30, 2017. Reason: Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities a…. Check the official notice for the remedy. Verify recall #D-1118-2017 with the FDA Drug before acting.

The recall

PD-Rx Pharmaceuticals, Inc. issued this low-severity FDA Drug recall-Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities a….

Low
severity level
Class III
classification
August 30, 2017
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-1118-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Drug action (record #D-1118-2017) was formally reported on August 30, 2017, with the manufacturer initiating the action on August 11, 2017. It is classified under Low severity (Class III), with a current status of Terminated. PD-Rx Pharmaceuticals, Inc. is listed as the recalling firm, operating out of Oklahoma City, OK. Federal records list the affected scope as 3440 bottles.

The documented reason for this recall is: Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test . Distribution data in the federal record shows the product reached: Nationwide.. 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

0100200300400500600 20052008201120142017202020232026 146
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Low

Affected scope

3440 bottles

Related Recalls

6

0 from same agency

Product description

Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-791-14), c) 21-count bottle (NDC 55289-791-21), d) 30-count bottle (NDC 55289-791-30), e) 60-count bottle (NDC 55289-791-60), Packaged by PD-Rx Pharmaceuticals, Incorporated, Oklahoma City, OK. 73127 Mfg: KVK-Tech, Inc. Newtown, PA 18940

Reason for recall

Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Low (Class III)
Status Terminated
Recall number D-1118-2017
Date reported August 30, 2017
Date initiated August 11, 2017
Recalling firm PD-Rx Pharmaceuticals, Inc.
Firm location Oklahoma City, OK
Affected scope 3440 bottles
Distribution Nationwide.

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-1118-2017) 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?
Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-791-14), c) 21-count bottle (NDC 55289-791-21), d) 30-count bottle (NDC 55289-791-30), e) 60-count bottle (NDC 55289-791-60), Packaged by PD-Rx Pharmaceuticals, Incorporated, Oklahoma City, OK. 73127 Mfg: KVK-Tech, Inc. Newtown, PA 18940. Recalled by PD-Rx Pharmaceuticals, Inc.. Units affected: 3440 bottles.
Why was this product recalled?
Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .
Which agency issued this recall?
This recall was issued by the FDA Drug on August 30, 2017. Severity: Low. Recall number: D-1118-2017.
Where was the recalled product distributed?
Distribution: Nationwide..
How do I check if my product is affected by a recall?
Check the product description and recall number (D-1118-2017) 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

Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.

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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 August 30, 2017. 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.