Recall events
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Event 85183
Event summary
Timeline bucket March 18, 2020
Product types Drug
Classifications Class II
Statuses Terminated
Recalling firm wording Aurobindo Pharma USA 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
9 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 9
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01
D-1229-2020
Recall number D-1229-2020
Initiated March 18, 2020
Classification Class II
Status Terminated
Quantity 14194 units
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Code information Lot #: 058180015A, 058180016A, Exp. Date 07/2021; 05818017B1, Exp. Date 09/2021
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[17696]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 9
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-059-99
D-1230-2020
Recall number D-1230-2020
Initiated March 18, 2020
Classification Class II
Status Terminated
Quantity 4332 units
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Code information Lot #: 059180023A, 059180024A and 059180025A, Exp. Date 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[38]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 9
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01
D-1231-2020
Recall number D-1231-2020
Initiated March 18, 2020
Classification Class II
Status Terminated
Quantity 57337 units
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Code information Lot #: 060180017A, 060180019B1, 060180020A and 060180021A, Exp. Date 06/2021
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[16738]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 9
Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99
D-1232-2020
Recall number D-1232-2020
Initiated March 18, 2020
Classification Class II
Status Terminated
Quantity 26625 units
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Code information Lot #: 198180048A, Exp. Date 04/2021; 198180061A, Exp. Date 06/2020; 19819017A1, Exp. Date 02/2021
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[15445]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 9
Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, NDC 65862-247-08
D-1233-2020
Recall number D-1233-2020
Initiated March 18, 2020
Classification Class II
Status Terminated
Quantity 8040 units
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Code information Lot #: 24719001A1, Exp. Date 03/2021
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[5366]
FDA event record
· Exact recall-number query on openFDA
drug · product 6 of 9
Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90
D-1234-2020
Recall number D-1234-2020
Initiated March 18, 2020
Classification Class II
Status Terminated
Quantity 26976 units
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Code information Lot #: 05319004A1, Exp. Date 03/2022
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[17493]
FDA event record
· Exact recall-number query on openFDA
drug · product 7 of 9
Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34
D-1235-2020
Recall number D-1235-2020
Initiated March 18, 2020
Classification Class II
Status Terminated
Quantity 56208 units
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Code information Lot #: 031180028A, Exp. Date 03/2021
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[15912]
FDA event record
· Exact recall-number query on openFDA
drug · product 8 of 9
Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01
D-1236-2020
Recall number D-1236-2020
Initiated March 18, 2020
Classification Class II
Status Terminated
Quantity 2101 units
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Code information Lot #: 105180004A, Exp. Date 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[5268]
FDA event record
· Exact recall-number query on openFDA
drug · product 9 of 9
Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-046-01
D-1237-2020
Recall number D-1237-2020
Initiated March 18, 2020
Classification Class II
Status Terminated
Quantity 14707 units
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Code information Lot #: 046180056A, Exp. Date 05/2020
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[17622]
FDA event record
· Exact recall-number query on openFDA
