Direct Rx recalls
14 official recalls and safety alerts involving Direct Rx since 2022-03, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Direct Rx or the relevant agency.
- 2026-07-01
USDirect Rx recalls DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- 2025-08-13
- US
Direct Rx recalls Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc.,…
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- 2025-04-23
- US
Direct Rx recalls CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
FDA · DrugDirect RxPhysicians and medical facilities in 5 states: AL, CA, FL, GA, IDOfficial notice → - 2024-11-13
- US
Direct Rx recalls Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA…
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
- 2023-04-12
- US
Direct Rx recalls Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and…
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
- 2023-04-05
- US
- 2023-01-18
- US
Direct Rx recalls Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA…
cGMP deviation: discontinue of stability support for product.
- 2022-09-21
- US
Direct Rx recalls Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo,…
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
- 2022-06-08
- US
Direct Rx recalls Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc.…
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- 2022-06-01
- US
Direct Rx recalls Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods…
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
- US
Direct Rx recalls Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for:…
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
- 2022-03-30
- US
Direct Rx recalls Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 Mfg. For SOLA…
Defective Container: Leaking containers.
- 2022-03-16
- US
Direct Rx recalls Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct…
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
- 2022-03-09
- US
Direct Rx recalls Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma…
Failed impurities/degradation specifications