Home / Recalls / Acella Pharmaceuticals, LLC / D-0014-2026

D-0014-2026 Class II Ongoing

Recalled by Acella Pharmaceuticals, LLC — Alpharetta, GA

Recall Details

Product Type: Drugs
Report Date: October 15, 2025
Initiation Date: September 29, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4,680 500-count bottles

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.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: P24ZLK1, Exp 5/31/2027

Other recalls by Acella Pharmaceuticals, LLC

D-0490-2024 Class III — Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, M (April 24, 2024)
D-0069-2023 Class III — Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x (November 14, 2022)
D-0074-2023 Class III — Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing (November 14, 2022)
D-0070-2023 Class III — Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x (November 14, 2022)
D-0399-2021 Class I — NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count b (April 29, 2021)
D-0395-2021 Class I — NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count b (April 29, 2021)
D-0396-2021 Class I — NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-count b (April 29, 2021)
D-0397-2021 Class I — NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only Ma (April 29, 2021)
D-0398-2021 Class I — NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx onl (April 29, 2021)
D-0035-2021 Class I — NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, (September 17, 2020)