Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.
Reported: October 15, 2025 Initiated: September 29, 2025 #D-0014-2026
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.
Reason for Recall
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Details
- Recalling Firm
- Acella Pharmaceuticals, LLC
- Units Affected
- 4,680 500-count bottles
- Distribution
- Nationwide in the USA
- Location
- Alpharetta, GA
Frequently Asked Questions
What product 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.. Recalled by Acella Pharmaceuticals, LLC. Units affected: 4,680 500-count bottles.
Why was this product recalled? ▼
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 15, 2025. Severity: Moderate. Recall number: D-0014-2026.
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