Class II · Moderate risk
Doxycycline
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Doxycycline Hyclate Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.
Affected NDC
42192-0501-05
Compare with the code on your package — it is the most precise check available.
Drug: Doxycycline Category: Antibiotic
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Doxycycline Doxycycline hyclate NDC 42192-0501 |
100 mg/1 | Tablet, Coated Oral |
Acella Pharmaceuticals, LLC | Rx |
- Recalling firm
- Acella Pharmaceuticals, LLC
- NDC code
- 42192-501-05
- Origin
- GA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0014-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Doxycycline recalls
See all
Class II · Moderate risk
Doxycycline Hyclate Tablets
cGMP deviations: Temperature abuse
Class II · Moderate risk
Doxycycline Capsules
cGMP deviations: Temperature abuse
Class II · Moderate risk
Doxycycline Capsules
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Doxycycline Hyclate Tablets
Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.
Other recalls by Acella Pharmaceuticals, LLC
All 2025 recalls
Class II · Moderate risk
Naproxen Oral Suspension
Chemical contamination; presence of lead and lithium above specification
Class III · Low risk
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser
Subpotent drug
Class III · Low risk
Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Class III · Low risk
Phenytoin Sodium Injection
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
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