Direct Rx recalls
Every recall we track for Direct Rx — 37 in all, from 2019–2026 — plus the complaints and injury reports the public filed about them. 4 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Direct Rx peaked in 2023 (14); 37 since 2017. 11% rated “stop using now”.
All FDA recall records for Direct Rx since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 1 | 0 | 0 | 2 |
| 2020 | 2 | 0 | 0 | 1 | 3 |
| 2021 | 0 | 0 | 2 | 1 | 3 |
| 2022 | 0 | 1 | 3 | 6 | 10 |
| 2023 | 0 | 1 | 2 | 11 | 14 |
| 2024 | 0 | 0 | 0 | 1 | 1 |
| 2025 | 1 | 0 | 1 | 1 | 3 |
| 2026 (to date) | 0 | 0 | 0 | 1 | 1 |
Most common reasons for Direct Rx recalls
What to do if you have a recalled Direct Rx product
- Match the NDC and lot number on your bottle or box to the recall.
- Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
- Report side effects to FDA MedWatch.
All Direct Rx recalls
20 shown- UnratedDrug
Direct 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
Direct Rx recalls DULOXETINE D/R 30mg capsules (NDC 61919-482-30) and 60-capsule packs (NDC 61919-482-60) due to N-nitroso-duloxetine impurity exceeding FDA safety limits. Affected lots expire 04/30/2027.
Direct RxJun 22, 2026 - UnratedDrug
Direct Rx recalls Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge
Direct Rx recalls 20mg Duloxetine 30-count bottles due to nitrosamine impurity exceeding safety limits. Consumers should check lot numbers and contact the manufacturer for details.
Direct RxMar 7, 2025 - Lower riskDrug
Direct Rx recalls CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx,
Direct Rx recalls 0.3% Ciprofloxacin Ophthalmic Solution bottles where the cap spike gets stuck in the nozzle, making it impossible to dispense the solution. Affected lots have specific expiration dates.
Direct RxJan 31, 2025 - UnratedDrug
Direct Rx recalls Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT
Direct Rx recalls 800mg ibuprofen tablets (Motrin) that failed stability testing for impurities. Products with NDC codes 61919-0621-15 to 61919-0621-72 are affected. No remedy specified in official notice.
Direct RxAug 9, 2024 - Use cautionDrug
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
Direct Rx is recalling specific lots of Alprazolam 1 mg tablets due to potential cross-contamination. Check your bottle's NDC and lot number immediately.
Direct RxMar 22, 2023 - UnratedDrug
Direct Rx recalls Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC
Direct Rx recalls 1 mg Glimepiride tablets (NDC 61919-0723-30 and 61919-0723-90) due to cGMP deviations. Affected lots expire by 5/31/2024 and 1/31/2024. Consumers should check their bottles for lot numbers.
Direct RxMar 13, 2023 - Lower riskDrug
Direct Rx recalls Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive,
Direct Rx recalls 0.5% moxifloxacin eye drops due to stability concerns. Affected lots expire 4/30/23. Contact for return instructions.
Direct RxNov 2, 2022 - Lower riskDrug
Direct Rx recalls Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534,
Direct Rx recalls 0.1% Triamcinolone Acetonide cream tubes due to reported gritty texture and lack of effectiveness. Consumers should check product details and contact the manufacturer for guidance.
Direct RxSep 12, 2022 - UnratedDrug
Direct Rx recalls Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA
Direct Rx recalls 100mg Zonisamide capsules due to quality control gaps in microbiology testing. Affected lots from June 2023 expire June 30, 2023. No remedy specified in official notice.
Direct RxMay 13, 2022 - UnratedDrug
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
Direct Rx recalls Losartan Pot/HCTZ 100/12.5 mg 90-tab tablets (NDC 72189-290-90) due to AZIDO impurity levels exceeding safety limits. Affected lots manufactured by Macleods Pharma USA, Inc. in Plainsboro, NJ.
Direct RxMay 11, 2022 - Use cautionDrug
Direct Rx recalls Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin
Direct Rx recalls specific lots of Losartan Pot./HCTZ 100/12.5 mg tablets due to azido impurity levels exceeding acceptable limits.
Direct RxMay 5, 2022 - UnratedDrug
Direct Rx recalls Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and
Direct Rx recalls 60-count Alprazolam C-IV 1mg bottles due to potential cross-contamination at the contract manufacturer. Affected lots expire May 2022.
Direct RxMar 4, 2022 - Lower riskDrug
Direct Rx recalls Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By
Direct Rx recalls 0.5% moxifloxacin eye drops due to failed impurities and degradation tests. Products with specific lot numbers and expiration dates are affected. Consumers should check their packaging for details.
Direct RxFeb 17, 2022 - Lower riskDrug
Direct Rx recalls Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534
Direct Rx recalls 150mL Diclofenac Sodium Topical Solution 1.5% due to leaking containers. This could lead to medication exposure risks.
Direct RxDec 7, 2021 - UnratedDrug
Direct Rx recalls Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For
Direct Rx recalls 30-count Zonisamide 100mg capsules due to quality control gaps in microbiology testing. Affected lots from May 2023 expire May 31, 2023. Stop using immediately.
Direct RxSep 14, 2021 - Lower riskDrug
Direct Rx recalls Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx
Direct Rx recalls 10mg Nortriptyline capsules due to manufacturing errors affecting ingredient quality. Affected lots may contain incorrect active ingredient levels.
Direct RxMar 2, 2021 - UnratedDrug
Direct Rx recalls Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90
Direct Rx recalls Metformin HCL E/R 500mg tablets due to detected N-Nitrosodimethylamine (NDMA) impurity exceeding safe levels. Consumers should check product details and follow official instructions.
Direct RxOct 12, 2020 - Stop using nowDrug
Direct Rx recalls Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC
Direct Rx recalls 300mg ranitidine tablets due to detected NDMA impurity. This chemical has been linked to potential health risks. Affected products were distributed with specific NDC and lot numbers.
Direct RxJan 15, 2020 - Stop using nowDrug
Direct Rx recalls Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC
FDA recalls Direct Rx Losartan Potassium 100mg tablets due to impurity NMBA above safe levels. Consumers with this specific product should stop using it.
Direct RxApr 30, 2019 - Use cautionDrug
Direct Rx recalls Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent
Direct Rx recalls specific lots of Losartan Pot/HCTZ 50/12.5 mg tablets due to trace amounts of the impurity N-Methylnitrosobutyric acid (NMBA).
Direct RxMar 12, 2019
Direct Rx recall questions
How many recalls has Direct Rx had?
37 recalls from Direct Rx are on record with U.S. safety agencies, from 2019–2026.
What is the most recent Direct Rx recall?
Direct 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, dated Jun 22, 2026. Every Direct Rx recall is listed on this page, newest first.
Why are Direct Rx products recalled?
The most common reasons on record: cGMP deviations (11); CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . (3); CGMP Deviations: Presence of NDMA impurity detected in product. (2).
What should I do if I have a recalled Direct Rx product?
Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.
How do I get alerts for new Direct Rx recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.