Recall events
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Event 88872
Event summary
Timeline bucket October 18, 2021
Product types Drug
Classifications Class III
Statuses Terminated
Recalling firm wording MACLEODS 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
3 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 3
Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18 Tablets (3 x 6 Unit-Dose Tablets, NDC 33342-088-41) Rx only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536l Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA
D-0078-2022
Recall number D-0078-2022
Initiated October 18, 2021
Classification Class III
Status Terminated
Quantity 135,082 Blister Packs/2,431,476 tablets
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Code information Lot #: BRJ2112A, BRJ2113A, BRJ2114A, BRJ2114B, exp. date 04/2024
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[15712]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 3
Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-093-41
D-0079-2022
Recall number D-0079-2022
Initiated October 18, 2021
Classification Class III
Status Terminated
Quantity 13,260 Blister Packs/238,680 tablets
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Code information Lot #: BRL2102A, BRL2103A, exp. date 04/2025
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[12838]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 3
Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-094-41
D-0080-2022
Recall number D-0080-2022
Initiated October 18, 2021
Classification Class III
Status Terminated
Quantity 643,800 Blister Packs /888,336 Tablets
App-derived interpretation
Potency or specification failure
reason.potency_specification_failure · v1.0.0
Out-of-specification
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Code information Lot #: BRM2111A, BRM2112A, BRM2113A, BRM2114A, BRM2115A, BRM2116A, exp. date 04/2025
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[12875]
FDA event record
· Exact recall-number query on openFDA
