Food, drugs, devices › Macleods Pharma Usa Inc
Drug recall: Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 0
FDA enforcement event 89766 is a drug recall by Macleods Pharma Usa Inc of Plainsboro, NJ, initiated 10 Mar 2022 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 18% of the 325 drug enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 29 Jun 2023. Initiation: voluntary: firm initiated. Macleods Pharma Usa Inc has 21 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
Macleods Pharma Usa Inc, Plainsboro, NJ.
Reason for recall
"FAILED CONTENT UNIFORMITY SPECIFICATIONS"
Distribution
"USA Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0762-2022 | Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., BAddi, HImchal Pradesh, INDIA, NDC 33342-107-07. | 4872 bottles | Class III | Terminated | 13 Apr 2022 |
Context
Other enforcement events for Macleods Pharma Usa Inc
All 21 events for Macleods Pharma Usa Inc
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "FAILED CONTENT UNIFORMITY SPECIFICATIONS"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "USA Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 29 Jun 2023. "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.