HIGH

Acella Pharmaceuticals Recalls Doxycycline Hyclate Tablets Over Dissolution Issue

Acella Pharmaceuticals recalled 4,680 bottles of Doxycycline Hyclate Tablets on September 29, 2025. The recall follows failed dissolution specifications, which can affect medication efficacy. This recall includes 500-count bottles distributed nationwide in the USA.

Quick Facts at a Glance

Recall Date
September 29, 2025
Hazard Level
HIGH
Brands
Doxycycline, Acella Pharmaceuticals
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Acella Pharmaceuticals, LLC or your healthcare provider for guidance. Notification method: Letter

Product Details

The recalled product is Doxycycline Hyclate Tablets, USP 100 mg, in 500-count bottles. The lot number is P24ZLK1, with an expiration date of May 31, 2027.

The Hazard

The recall stems from stability testing that revealed the product did not meet dissolution specifications. This failure may compromise the effectiveness of the medication.

Reported Incidents

There have been no reported injuries or adverse events associated with this recall. The risk remains high due to potential ineffectiveness of the medication.

What to Do

Consumers and healthcare providers should stop using the recalled product immediately. Contact Acella Pharmaceuticals or your healthcare provider for guidance on next steps.

Contact Information

For more information, contact Acella Pharmaceuticals, LLC at their customer service line or visit their website.

Key Facts

  • Recall date: September 29, 2025
  • Quantity recalled: 4,680 bottles
  • Distribution: Nationwide in the USA
  • Hazard classification: Class II
  • Expiration date: May 31, 2027

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot #: P24ZLK1
Exp 5/31/2027
UPC Codes
42192-501
42192-501-50
42192-501-05
Affected States
ALL
Report Date
October 15, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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