Food, drugs, devices › Aidarex Pharmaceuticals LLC
Drug recall: Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceut
Aidarex Pharmaceuticals LLC (Corona, CA) initiated this drug recall on 22 May 2014; FDA lists 1 product record under event 68375, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 58% of the 313 drug enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 6 Nov 2014. Initiation: voluntary: firm initiated. Aidarex Pharmaceuticals LLC has 8 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Aidarex Pharmaceuticals LLC, Corona, CA.
Reason for recall
"Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg"
Distribution
"Nationwide in US: FL, SC, WA, WV, IN, AL, VA, MS"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0042-2015 | Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India | 531 bottles | Class II | Terminated | 29 Oct 2014 |
Context
Other enforcement events for Aidarex Pharmaceuticals LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 27 Jun 2018 | Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. | Drug | Class III | 3 |
| 10 Apr 2018 | Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00 | Drug | Class III | 1 |
| 5 Sep 2017 | ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmac | Drug | Class III | 1 |
| 5 Sep 2017 | Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK- | Drug | Class III | 1 |
| 1 Jun 2016 | CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE | Drug | Class II | 1 |
| 1 Jun 2016 | CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 5 | Drug | Class III | 1 |
| 1 Jun 2016 | Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG: | Drug | Class III | 1 |
All 8 events for Aidarex Pharmaceuticals LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in US: FL, SC, WA, WV, IN, AL, VA, MS"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Nov 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.