Recall events
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Event 81457
Event summary
Timeline bucket November 02, 2018
Product types Drug
Classifications Class II and Class III
Statuses Terminated
Recalling firm wording Sandoz 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
6 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 6
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz Inc. Princeton, NJ 08540
D-0257-2019
Recall number D-0257-2019
Initiated November 02, 2018
Classification Class III
Status Terminated
Quantity 14366 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Cross Contamination with Other Products
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Cross Contamination with Other Products
Code information Lots: a) JB4952, JA7322 Exp. 03/2020; b) JA7324, Exp.03/2020
Distribution pattern Nationwide within the United States
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[16282]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 6
Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. Princeton, NJ 08540; NDC 0781-1695-01
D-0258-2019
Recall number D-0258-2019
Initiated November 02, 2018
Classification Class II
Status Terminated
Quantity 18,832 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Cross Contamination with Other Products
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Cross Contamination with Other Products
Code information Lots: a) JA9535 Exp. 05/2021.
Distribution pattern Nationwide within the United States
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[16862]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 6
Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-223-00
D-0259-2019
Recall number D-0259-2019
Initiated November 02, 2018
Classification Class II
Status Terminated
Quantity 7817 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Cross Contamination with Other Products
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Cross Contamination with Other Products
Code information Lot #: HZ7896, Exp. 05/2021
Distribution pattern Nationwide within the United States
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[2032]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 6
Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-225-00
D-0260-2019
Recall number D-0260-2019
Initiated November 02, 2018
Classification Class II
Status Terminated
Quantity 5100 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Cross Contamination with Other Products
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Cross Contamination with Other Products
Code information Lot #: JA3077, Exp. 05/2021
Distribution pattern Nationwide within the United States
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[2047]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 6
Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-222-00
D-0261-2019
Recall number D-0261-2019
Initiated November 02, 2018
Classification Class II
Status Terminated
Quantity 1550 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Cross Contamination with Other Products
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Cross Contamination with Other Products
Code information Lot #: JA9534, Exp. 05/2021
Distribution pattern Nationwide within the United States
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[1432]
FDA event record
· Exact recall-number query on openFDA
drug · product 6 of 6
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Sandoz Inc. Princeton, NJ 08540,NDC 16714-439-01
D-0262-2019
Recall number D-0262-2019
Initiated November 02, 2018
Classification Class III
Status Terminated
Quantity 23053 bottles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Cross Contamination with Other Products
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Cross Contamination with Other Products
Code information Lot #: JA7319, JA 7320, JA7321, Exp. 03/2020
Distribution pattern Nationwide within the United States
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[15023]
FDA event record
· Exact recall-number query on openFDA
