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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Doxycycline, Acella Pharmaceuticals
- Product type
- Doxycycline Hyclate Tablet 100 mg (Rx) 500-count bottle
- Model numbers
- Lot P24ZLK1, Exp 5/31/2027, NDC 42192-501-05
- UPC codes
- 42192-501, 42192-501-50, 42192-501-05
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 29, 2025
Reported by FDA DRUG
October 15, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
Doxycycline hyclate is a broad-spectrum antibiotic used to treat infections. The product in question is a 100 mg tablet, distributed nationwide as a prescription medication.
Why This Is Dangerous
The dissolution failure means the drug may not dissolve as expected in the body, potentially reducing efficacy. This can lead to suboptimal treatment outcomes if the patient relies on the tablet for infection control.
Industry Context
This recall is not described as part of a broader industry pattern in the available information.
Real-World Impact
Patients with the affected lot may experience reduced therapeutic effect. The recall emphasizes stopping use and seeking guidance from healthcare providers.
Practical Guidance
How to identify if yours is affected
- Check the bottle for NDC 42192-501-05 and Lot P24ZLK1
- Verify the Expiry Date 5/31/2027
- Confirm quantity is 500 tablets per bottle and 4,680 total bottles recalled
Where to find product info
Refer to the FDA enforcement page for D-0014-2026 and contact Acella Pharmaceuticals for instructions
What timeline to expect
Remedies typically involve replacement or refund as directed by the manufacturer; processing timelines vary by pharmacy and provider
If the manufacturer is unresponsive
- Document all communications
- Escalate to consumer protection or FDA recall program if the manufacturer is unresponsive
- Consider contacting your pharmacist for guidance on alternatives
How to prevent similar issues
- Always verify the NDC and lot number before taking prescription meds
- Monitor recall notices from the FDA and manufacturers
- Choose reputable pharmacies that provide recall updates
- Ask your pharmacist to confirm product integrity before dispensing medicines
Documentation advice
Keep the recall notice, bottle labels showing NDC and lot, and all correspondence with the manufacturer and healthcare providers
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Product Details
NDC 42192-501-05; Lot P24ZLK1; Exp 5/31/2027; Quantity 4,680 bottles; Bottle count 500 per bottle; Distribution Nationwide in the USA; Rx Only; Sold through healthcare providers; Price not disclosed.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Lot P24ZLK1
- Nationwide distribution in USA
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Safety Guide
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