CLASS II Drug recall · Reported 29 Oct 2014 · FDA Enforcement Report

Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged recalled

Aidarex Pharmaceuticals is recalling Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by, distributed nationwide in the US. The recall was initiated on 22 May 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 39661-3 Exp. 07/15

Quantity recalled531 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0042-2015
FDA event ID: 68375
Recalling firm: Aidarex Pharmaceuticals, Corona, CA
Classification: Class II
Status: Terminated
Recall initiated: 22 May 2014
FDA classified: 23 Oct 2014
Reported: 29 Oct 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Drug class: Antibiotics

Timeline

22 May 2014	Recall initiated by company
23 Oct 2014	Classified by FDA	+154 days
29 Oct 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India

Where it was distributed

Nationwide in US: FL, SC, WA, WV, IN, AL, VA, MS

Nationwide Alabama Florida Indiana Mississippi South Carolina Virginia Washington West Virginia

Questions about this recall

Why was it recalled?

Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg

Which lots are affected?

Lot 39661-3 Exp. 07/15

Where was it sold?

Nationwide in US: FL, SC, WA, WV, IN, AL, VA, MS

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Aidarex Pharmaceuticals

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Reported	Class	Recall	Company	Reason	Where
1 Aug 2018Drug	CLASS III	Enalapril Maleate, USP 5MG recalled by Aidarex Pharmaceuticals	Aidarex Pharmaceuticals	Potency & Assay	Nationwide
1 Aug 2018Drug	CLASS III	Enalapril Maleate, USP 2.5MG recalled by Aidarex Pharmaceuticals	Aidarex Pharmaceuticals	Potency & Assay	Nationwide
1 Aug 2018Drug	CLASS III	Enalapril Maleate, USP 5MG recalled by Aidarex Pharmaceuticals	Aidarex Pharmaceuticals	Potency & Assay	Nationwide
23 May 2018Drug	CLASS III	Ferrous Sulfate recalled by Aidarex Pharmaceuticals	Aidarex Pharmaceuticals	Other	FL
1 Nov 2017Drug	CLASS III	Enalapril Maleate Tablets, USP, 5MG recalled by Aidarex Pharmaceuticals	Aidarex Pharmaceuticals	Potency & Assay	FL

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26 Mar 2025Drug	CLASS II	Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package recalledCiprofloxacin	FDC	Packaging Defects	Nationwide
15 Jan 2025Drug	CLASS II	Ciprofloxacin Ophthalmic Solution USP, 0.3% as base recalled by FDCCiprofloxacin	FDC	Packaging Defects	Nationwide
7 Aug 2024Drug	CLASS II	Ciprofloxacin ophthalmic solution USP, 0.3% as base recalled by FDCCiprofloxacin	FDC	Packaging Defects	Nationwide
25 Jan 2023Drug	CLASS II	Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl) recalled	Akorn	Manufacturing (CGMP) Deviations	Nationwide