CLASS III Drug recall · Reported 13 Apr 2022 · FDA Enforcement Report
Risedronate Sodium Tablets, USP, 5 mg recalled by Macleods Pharma Usa
Macleods Pharma Usa is recalling Risedronate Sodium Tablets, USP, 5 mg, distributed nationwide in the US. The recall was initiated on 10 Mar 2022 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0762-2022
- FDA event ID
- 89766
- Recalling firm
- Macleods Pharma Usa, Plainsboro, NJ
- Brand
- Risedronate Sodium
- Manufacturer
- Macleods Pharmaceuticals Limited
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 10 Mar 2022
- FDA classified
- 7 Apr 2022
- Reported
- 13 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 10 Mar 2022 | Recall initiated by company | |
| 7 Apr 2022 | Classified by FDA | +28 days |
| 13 Apr 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
FAILED CONTENT UNIFORMITY SPECIFICATIONS
Product as listed by the FDA
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.
Where it was distributed
USA Nationwide
Questions about this recall
Is Risedronate Sodium Tablets, USP, 5 mg recalled?
Yes. Macleods Pharma Usa recalled Risedronate Sodium Tablets, USP, 5 mg on 10 Mar 2022. The recall is Class III and its status is Terminated. Recall number D-0762-2022.
Why was it recalled?
FAILED CONTENT UNIFORMITY SPECIFICATIONS
Which lots are affected?
Lot #: BRD2001A, Exp 5/2022
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Macleods Pharma Usa
All 34| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets USP 150 mcg recalled by Macleods Pharma UsaLevothyroxine Sodium | Macleods Pharma Usa | Potency & Assay | Nationwide |
| Drug | CLASS II | Losartan Potassium and Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma Usa | Foreign Material | Nationwide |
| Drug | CLASS III | Levofloxacin Tablets, USP 500 mg recalled by Macleods Pharma Usa | Macleods Pharma Usa | Packaging Defects | Nationwide |
| Drug | CLASS II | Eszopiclone Tablets, USP 1 mg recalled by Macleods Pharma UsaEszopiclone | Macleods Pharma Usa | Packaging Defects | Nationwide |
| Drug | CLASS II | Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma Usa | Potency & Assay | Nationwide |
Other Risedronate recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Risedronate Sodium Delayed-release Tablets, 35 mg recalled | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS III | Risedronate Sodium Delayed-release Tablets, 35 mg recalled | Teva Pharmaceuticals U | Potency & Assay | Nationwide |