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Direct Rx recall records

8 reported ongoing

30 records in this archive. Latest source date Jun 22, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

Sep 12, 2022FDA drug enforcement

Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80.

CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.

Class IIReported completed

Distribution: Physicians and Medical Facilities in GA and ID

Official source

May 13, 2022FDA drug enforcement

Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mah...

CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.

Class IIReported terminated

Distribution: Nationwide to the U.S. market

Official source

May 11, 2022FDA drug enforcement

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 Pharma USA, Inc. Plainsboro, NJ 08540

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .

Class IIReported terminated

Distribution: FL

Official source

May 11, 2022FDA drug enforcement

Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .

Class IIReported terminated

Distribution: FL

Official source

May 11, 2022FDA drug enforcement

Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .

Class IIReported terminated

Distribution: FL

Official source

May 5, 2022FDA drug enforcement

Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30;...

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Class IIReported terminated

Distribution: AL, GA, FL, LA

Official source

Mar 4, 2022FDA drug enforcement

Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 61919-836-60

CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)

Class IIReported terminated

Distribution: FL, GA, LA

Official source

Mar 4, 2022FDA drug enforcement

Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-00...

CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)

Class IIReported terminated

Distribution: FL, GA, LA

Official source

Feb 17, 2022FDA drug enforcement

Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520, NDC 721...

Failed impurities/degradation specifications

Class IIReported terminated

Distribution: Florida

Official source

Dec 7, 2021FDA drug enforcement

Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 Mfg. For SOLA Pharmaceuticals Baton Rouge, LA, NDC 61919-6...

Defective Container: Leaking containers.

Class IIReported terminated

Distribution: Nationwide within the United States

Official source

Reasons in these listed records

CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

These examples come from this result page and are not a ranking of every recall reason.

Checking Direct Rx

Is there a recall on direct rx right now?

This archive contains 30 records, including 8 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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