Doxycycline Hyclate Tablets recall
FDA recall D-0014-2026 · initiated Sep 29, 2025
Acella Pharmaceuticals, LLC recalled Doxycycline Hyclate Tablets in Sep 2025 — an FDA Class II recall (D-0014-2026) because Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4,680 500-count bottles
Details
- Product
- Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.
- Recalling company
- Acella
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Sep 29, 2025
- FDA report date
- Oct 15, 2025
Frequently asked
- Was Doxycycline Hyclate Tablets recalled?
- Acella Pharmaceuticals, LLC recalled Doxycycline Hyclate Tablets in Sep 2025 — an FDA Class II recall (D-0014-2026) because Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Doxycycline Hyclate Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0014-2026 was: Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
- Is a recalled Doxycycline Hyclate Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Doxycycline Hyclate Tablets are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #: P24ZLK1, Exp 5/31/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0014-2026.