Why it was recalled
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Product description
Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.
Lot numbers, UPCs & expiration codes
Lot #: P24ZLK1, Exp 5/31/2027
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0014-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Sep 29, 2025
- FDA report date
- Oct 15, 2025
- Quantity
- 4,680 500-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Acella Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0014-2026, exactly as published.
Show all FDA fields
- City
- Alpharetta
- State
- GA
- Status
- Ongoing
- Country
- United States
- Event ID
- 97716
- Address
- 1880 Mcfarland Pkwy Ste 110
- Code information
- Lot #: P24ZLK1, Exp 5/31/2027
- Postal code
- 30005-1795
- Report date
- Oct 15, 2025
- Product type
- Drugs
- Recall number
- D-0014-2026
- Classification
- Class II
- Recalling firm
- Acella Pharmaceuticals, LLC
- Product quantity
- 4,680 500-count bottles
- Reason for recall
- Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 29, 2025
- Initial firm notification
- Letter
- Center classification date
- Oct 9, 2025