PlainRecalls
ModerateClass IITerminated

FDA Drug recall · Reported June 3, 2020

Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.

Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.

Recall #
D-1274-2020
Affected scope
68,376 bottles
Initiated
May 13, 2020
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
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West-Ward Columbus Inc recalled Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50… - a moderate-severity action.

Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50… was recalled by West-Ward Columbus Inc in June 3, 2020. Reason: Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded…. Check the official notice for the remedy. Verify recall #D-1274-2020 with the FDA Drug before acting.

The recall

West-Ward Columbus Inc issued this moderate-severity FDA Drug recall-Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded….

Moderate
severity level
Class II
classification
June 3, 2020
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-1274-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Drug action (record #D-1274-2020) was formally reported on June 3, 2020, with the manufacturer initiating the action on May 13, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. West-Ward Columbus Inc is listed as the recalling firm, operating out of Columbus, OH. Federal records list the affected scope as 68,376 bottles.

The documented reason for this recall is: Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result. Distribution data in the federal record shows the product reached: USA 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 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

68,376 bottles

Related Recalls

6

0 from same agency

Product description

Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.

Reason for recall

Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.

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-1274-2020
Date reported June 3, 2020
Date initiated May 13, 2020
Recalling firm West-Ward Columbus Inc
Firm location Columbus, OH
Affected scope 68,376 bottles
Distribution USA 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-1274-2020) 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?
Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.. Recalled by West-Ward Columbus Inc. Units affected: 68,376 bottles.
Why was this product recalled?
Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 3, 2020. Severity: Moderate. Recall number: D-1274-2020.
Where was the recalled product distributed?
Distribution: USA Nationwide.
How do I check if my product is affected by a recall?
Check the product description and recall number (D-1274-2020) 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 June 3, 2020. 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.