Recall events
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Event 75650
Event summary
Timeline bucket January 18, 2017
Product types Drug
Classifications Class II
Statuses Terminated
Recalling firm wording VistaPharm, Inc.
Dossier provenance
Source snapshots represented here
openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Device root-cause evidence is not applicable to this event.
No grouped product has the official product type device; this is not an unavailable-enrichment finding.
Complete imported group
Every recalled product in this event
11 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 11
Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16 fl. oz. (237 mL), 12 bottles per case (NDC 66689-008-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771
D-0457-2017
Recall number D-0457-2017
Initiated January 18, 2017
Classification Class II
Status Terminated
Quantity 67,955 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
Microbial contamination
reason.microbial_contamination · v1.0.0
contaminated with Burkholderia cepacia
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Code information a) Lot No. 422600 (Exp. 10/17), 420000 (Exp. 09/17), 416100 (Exp. 08/17), 417400 (Exp. 09/17) b) Lot No. 424200 (Exp. 10/17), 415500 (Exp. 03/18)
Distribution pattern Nationwide
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14924]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 11
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-023-04), b) 16 fl.oz. (473 mL), 12 bottles per case (NDC 66689-023-16), c) 50 unit dose cups of 15 mL per case, (NDC No. 66689-023-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771
D-0458-2017
Recall number D-0458-2017
Initiated January 18, 2017
Classification Class II
Status Terminated
Quantity 32,027 bottles and 16,310 unit dose cups
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
Microbial contamination
reason.microbial_contamination · v1.0.0
contaminated with Burkholderia cepacia
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Code information a). Lot No. 419000 (Exp. 03/17) b.) Lot No. 419800 (Exp. 03/17), 429100 (Exp. 06/17) c). Lot No. 418200 (Exp. 03/17), 430100 (Exp. 06/17), 423800 (Exp. 04/17), 413100 (Exp. 02/17), 410700 (Exp. 01/17)
Distribution pattern Nationwide
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14595]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 11
Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-031-50.
D-0459-2017
Recall number D-0459-2017
Initiated January 18, 2017
Classification Class II
Status Terminated
Quantity 3,496 unit dose cups
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
Microbial contamination
reason.microbial_contamination · v1.0.0
contaminated with Burkholderia cepacia
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Code information Lot No. 428700 (Exp. 11/17), 409500 (Exp.06/17)
Distribution pattern Nationwide
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14306]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 11
Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-036-50.
D-0460-2017
Recall number D-0460-2017
Initiated January 18, 2017
Classification Class II
Status Terminated
Quantity 12,059 unit dose cups
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
Microbial contamination
reason.microbial_contamination · v1.0.0
contaminated with Burkholderia cepacia
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Code information Lot No. 428700 (Exp. 11/17), 409500 (Exp. 06/17)
Distribution pattern Nationwide
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15910]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 11
Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per case (NDC No. 66689-037-50), b). 100 unit dose cups of 5 mL per case (NDC 66689-037-99), Rx only, Manufactured by VistaPharm, Largo, FL 33771.
D-0461-2017
Recall number D-0461-2017
Initiated January 18, 2017
Classification Class II
Status Terminated
Quantity 55,191 unit dose cups
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
Microbial contamination
reason.microbial_contamination · v1.0.0
contaminated with Burkholderia cepacia
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Code information a). Lot No. 428900, 425600 (Exp. 05/17); 421200 (Exp. 04/17), 413600 (Exp. 02/17), 411500 (Exp. 01/17), 417200 (Exp. 03/17) b). Lot No. 429300 (Exp. 06/17) ,426500 (Exp. 05/17), 420600 (Exp. 03/17), 417000 (Exp.03/17), 412900 (Exp. 01/17), 409900 (Exp. 01/17)
Distribution pattern Nationwide
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14180]
FDA event record
· Exact recall-number query on openFDA
drug · product 6 of 11
Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-038-50.
D-0462-2017
Recall number D-0462-2017
Initiated January 18, 2017
Classification Class II
Status Terminated
Quantity 18,437 unit dose cups
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
Microbial contamination
reason.microbial_contamination · v1.0.0
contaminated with Burkholderia cepacia
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Code information Lot No. 422800 (1Exp. 0/17), 430500 (Exp. 12/17), 424000 (Exp. 10/17), 412500 (Exp. 07/17), 405500 (Exp. 05/17), 414900 (Exp. 09/17)
Distribution pattern Nationwide
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15458]
FDA event record
· Exact recall-number query on openFDA
drug · product 7 of 11
Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-039-50.
D-0463-2017
Recall number D-0463-2017
Initiated January 18, 2017
Classification Class II
Status Terminated
Quantity 7,404 unit dose cups
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
Microbial contamination
reason.microbial_contamination · v1.0.0
contaminated with Burkholderia cepacia
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Code information a). Lot No. 728300 (Exp. 11/17), 423200 (Exp. 10/17), 418400 (Exp. 09/17), 411100 (Exp. 07/17), 406500 (Exp. 06/17)
Distribution pattern Nationwide
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15453]
FDA event record
· Exact recall-number query on openFDA
drug · product 8 of 11
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No. 66689-401-50), b). 500 mL, 12 bottles per case (NDC No. 66689-403-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771.
D-0464-2017
Recall number D-0464-2017
Initiated January 18, 2017
Classification Class II
Status Terminated
Quantity 42,776 unit dose cups and 17,403 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
Microbial contamination
reason.microbial_contamination · v1.0.0
contaminated with Burkholderia cepacia
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Code information a). Lot No. 427900, 426700 (Exp. 11/17), 424800, 423600 (Exp. 10/17), 420800 (09/17), 416300 (08/17), 407700, 407300 (Exp. 06/17), 405900, 403900 (Exp. 05/17) b). Lot No. 426900 (Exp. 11/17), 404700 (Exp. 05/17), 390200 (Exp. 02/17)
Distribution pattern Nationwide
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15386]
FDA event record
· Exact recall-number query on openFDA
drug · product 9 of 11
Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 bottles per case (NDC No. 66689-695-30), b). 1 liter (1000 mL), 4 bottles per case, (NDC No. 66689-695-79), Rx only, Manufactured by VistaPharm, Largo, FL 33771.
D-0465-2017
Recall number D-0465-2017
Initiated January 18, 2017
Classification Class II
Status Terminated
Quantity 127,193 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
Microbial contamination
reason.microbial_contamination · v1.0.0
contaminated with Burkholderia cepacia
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Code information a). Lot No. 416600 (Exp. 09/17) b). Lot No.449100 , 447500 (Exp. 04/18), 421800 (Exp. 10/17), 418600 (Exp. 09/17), 408700 (Exp. 06/17), 411900 (Exp. 07/17), 413800 (Exp. 08/17), 416500 (Exp. 09/17), 408500 (Exp. 06/17), 389800 (Exp. 01/17), 429900 (Exp. 12/17), 406300, 406100 (Exp. 05/17), 429700 (Exp. 12/17), 427300, 427100, 425900 (11/17)
Distribution pattern Nationwide
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16817]
FDA event record
· Exact recall-number query on openFDA
drug · product 10 of 11
Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL), 4 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-695-79.
D-0466-2017
Recall number D-0466-2017
Initiated January 18, 2017
Classification Class II
Status Terminated
Quantity 14,368 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
Microbial contamination
reason.microbial_contamination · v1.0.0
contaminated with Burkholderia cepacia
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Code information Lot No. 423000 (Exp. 10/17), 415100 (Exp. 08/17)
Distribution pattern Nationwide
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15660]
FDA event record
· Exact recall-number query on openFDA
drug · product 11 of 11
Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-711-16.
D-0467-2017
Recall number D-0467-2017
Initiated January 18, 2017
Classification Class II
Status Terminated
Quantity 3,354 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
Microbial contamination
reason.microbial_contamination · v1.0.0
contaminated with Burkholderia cepacia
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Code information Lot No. 388700 (Exp. 01/17)
Distribution pattern Nationwide
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15849]
FDA event record
· Exact recall-number query on openFDA
