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Lower risk Drug recall · FDA · Published November 2, 2022

Direct Rx Moxifloxacin Eye Drops Recall: Stability Issue

Direct Rx recalls 0.5% moxifloxacin eye drops due to stability concerns. Affected lots expire 4/30/23. Contact for return instructions.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0101-2023DrugDirect Rx ›
Take action

Contact the company

Recalling firmDirect Rx94 Worldwide Dr · Dawsonville, GA 30534-6828
✎ GovInfoNow plain-language explainer

Direct Rx is recalling certain moxifloxacin eye drops because they may not stay stable after production. This could affect the medicine's effectiveness if used. Read more at govinfonow.com/recall/34235-direct-rx-moxifloxacin-eye-drops-recall-stability-issue.

Source Summary by GovInfoNow · govinfonow.com/recall/34235-direct-rx-moxifloxacin-eye-drops-recall-stability-issue · Updated August 18, 2026 · FDA enforcement record: FDA #D-0101-2023

Cite this page

“Direct Rx Moxifloxacin Eye Drops Recall: Stability Issue.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34235-direct-rx-moxifloxacin-eye-drops-recall-stability-issue. Based on FDA recall #D-0101-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0101-2023%22&limit=1).

The FDA announced on 2022-11-02 that Direct Rx is recalling Moxifloxacin Ophthalmic Solution due to cGMP deviations involving the discontinuation of stability support. The recall involves one bottle distributed in Florida.

How to tell if you have it

  • Brand: Direct Rx
  • Product: Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL
  • NDC: 72189-0334-05
  • Lot #: 07MA2232
  • Expiration: 4/30/23
  • Distribution: FL

The hazard

The product was recalled because of cGMP deviations related to the discontinuation of stability support for the product.

Context

GovInfoNow's records show Direct Rx has had 19 other recalls since 2019-03-12. Recent brand recalls include a DULOXETINE D/R 30mg Caps recall on 2026-06-22 for N-nitroso-duloxetine impurity risk, a Duloxetine 20mg bottle recall on 2025-03-07 for nitrosamine impurity risk, and a Ciprofloxacin Ophthalmic Solution recall on 2025-01-31 for a cap stuck in the nozzle. Other recent recalls of similar products include AbbVie's PRED MILD Eye Drops recall on 2026-05-18 due to stability issues, Apotex's Paxil CR 37.5mg Tablets recall on 2026-08-13 for failed stability testing, and Micro Labs' Dorzolamide/Timolol Eye Drops recall on 2026-07-22 for broken caps causing undeliverable drops.

How to tell if you have this one

Check for the lot number 07MA2232 on the packaging. The product expires April 30, 2023. Only the specific lot is affected.

  • Brand
    Direct Rx
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the lot number 07MA2232 on the packaging to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed in Florida.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: yesFL

FDA distribution: “FL” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

1. Firm started the recall: Nov 2, 202212. FDA classified it Class II: Jan 11, 202323. Published in FDA’s Enforcement Report: Jan 18, 202334. FDA terminated the recall: Sep 30, 2024420222024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Other Direct Rx recalls

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
June 22, 2026

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Ajanta Pharma · September 17, 2026Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company recalls Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with
Insight Pharmaceuticals · September 15, 2026K.C. Pharmaceuticals, Inc. recalls Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO
Leader / TopCare / Crocodile Tears · September 11, 2026

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0101-2023 (November 2, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0101-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA