Food, drugs, devices › Acella Pharmaceuticals, LLC
Drug recall: Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alphar
FDA enforcement event 97716 is a drug recall by Acella Pharmaceuticals, LLC of Alpharetta, GA, initiated 29 Sep 2025 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 79% of the 322 drug enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Acella Pharmaceuticals, LLC has 8 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Acella Pharmaceuticals, LLC, Alpharetta, GA.
Reason for recall
"Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications."
Distribution
"Nationwide in the USA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0014-2026 | Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05. | 4,680 500-count bottles | Class II | Ongoing | 15 Oct 2025 |
Context
Other enforcement events for Acella Pharmaceuticals, LLC
All 8 events for Acella Pharmaceuticals, LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the USA"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.