PlainRecalls
ModerateClass IITerminated

FDA Drug recall · Reported June 12, 2013

Metronidazole Tablets, USP, 500 mg, packaged in a) 10-count tablets per bottle (NDC 54868-0158-3); b) 14-count tablets per bottle (NDC 54868-0158-1); c) 20-count tablets per bottle (NDC 54868-0158-5); d) 21-count tablets per bottle (NDC 54868-0158-0); e) 30-count tablets per bottle (NDC 54868-0158-8), Rx only, Mfg. By: Pliva Krakow Pharma. Comp., Krakow, Poland; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146.

Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.

Recall #
D-547-2013
Affected scope
25230 tablets: a) 190 bottles, b) 743 bottles, c) 293 bottles, d) 8 bottles, e) 230 bottles
Initiated
April 6, 2011
Compiled from official public sources by the editorial team.
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Physicians Total Care, Inc. recalled Metronidazole Tablets, USP, 500 mg, packaged in a) 10-count tablets per bottle (NDC 54868… - a moderate-severity action.

Metronidazole Tablets, USP, 500 mg, packaged in a) 10-count tablets per bottle (NDC 54868… was recalled by Physicians Total Care, Inc. in June 12, 2013. Reason: Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.. Check the official notice for the remedy. Verify recall #D-547-2013 with the FDA Drug before acting.

The recall

Physicians Total Care, Inc. issued this moderate-severity FDA Drug recall-Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications..

Moderate
severity level
Class II
classification
June 12, 2013
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-547-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Drug action (record #D-547-2013) was formally reported on June 12, 2013, with the manufacturer initiating the action on April 6, 2011. It is classified under Moderate severity (Class II), with a current status of Terminated. Physicians Total Care, Inc. is listed as the recalling firm, operating out of Tulsa, OK. Federal records list the affected scope as 25230 tablets: a) 190 bottles, b) 743 bottles, c) 293 bottles, d) 8 bottles, e) 230 bottles.

The documented reason for this recall is: Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications. 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, 5 from FDA Drug - 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.

Drugs & Medications recalls over time

Where this recall sits in its category - 14,287 drugs & medications recalls on record

-50005001,0001,5002,000 2006201220152018202120242026 263
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 moderate severity.

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

Severity

Moderate

Affected scope

25230 tablets: a) 190 bottles, b) 743 bottles, c) 293 bottles, d) 8 bottles, e) 230 bottles

Related Recalls

6

5 from same agency

Product description

Metronidazole Tablets, USP, 500 mg, packaged in a) 10-count tablets per bottle (NDC 54868-0158-3); b) 14-count tablets per bottle (NDC 54868-0158-1); c) 20-count tablets per bottle (NDC 54868-0158-5); d) 21-count tablets per bottle (NDC 54868-0158-0); e) 30-count tablets per bottle (NDC 54868-0158-8), Rx only, Mfg. By: Pliva Krakow Pharma. Comp., Krakow, Poland; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146.

Reason for recall

Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number D-547-2013
Date reported June 12, 2013
Date initiated April 6, 2011
Recalling firm Physicians Total Care, Inc.
Firm location Tulsa, OK
Affected scope 25230 tablets: a) 190 bottles, b) 743 bottles, c) 293 bottles, d) 8 bottles, e) 230 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-547-2013) 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?
Metronidazole Tablets, USP, 500 mg, packaged in a) 10-count tablets per bottle (NDC 54868-0158-3); b) 14-count tablets per bottle (NDC 54868-0158-1); c) 20-count tablets per bottle (NDC 54868-0158-5); d) 21-count tablets per bottle (NDC 54868-0158-0); e) 30-count tablets per bottle (NDC 54868-0158-8), Rx only, Mfg. By: Pliva Krakow Pharma. Comp., Krakow, Poland; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146.. Recalled by Physicians Total Care, Inc.. Units affected: 25230 tablets: a) 190 bottles, b) 743 bottles, c) 293 bottles, d) 8 bottles, e) 230 bottles.
Why was this product recalled?
Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 12, 2013. Severity: Moderate. Recall number: D-547-2013.
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-547-2013) 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 June 12, 2013. 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.