CLASS II Drug recall · Reported 21 Aug 2019 · FDA Enforcement Report
Tamsulosin Hydrochloride Capsules, USP 0.4 mg recalled
Macleods Pharma Usa is recalling Tamsulosin Hydrochloride Capsules, USP 0.4 mg, distributed nationwide in the US. The recall was initiated on 17 Jul 2019 and the FDA has classified it as Class II.
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-1844-2019
- FDA event ID
- 83414
- Recalling firm
- Macleods Pharma Usa, Plainsboro, NJ
- Manufacturer
- Macleods Pharmaceuticals Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jul 2019
- FDA classified
- 28 Aug 2019
- Reported
- 21 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Bladder & Prostate Medication
Timeline
| 17 Jul 2019 | Recall initiated by company | |
| 21 Aug 2019 | Published in enforcement report | +35 days |
| 28 Aug 2019 | Classified by FDA | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 33342-159-11), b) 500 count (NDC 33342-159-15) and c) 1000 count (NDC 33342-159-44) bottles, Manufactured : Macleods Pharma USA, Inc Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himchal Pradesh, INDIA
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
a) BTP803A, exp 08/2020; b) BTP802A, exp 07/2020, BTP901A, exp 12/2020; c) BTP802B, exp 07/2020
Where was it sold?
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 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 Tamsulosin recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tamsulosin Hydrochloride Capsules, USP, 0.4 mg recalledTamsulosin Hydrochloride | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Tamsulosin Hydrochloride Capsules, USP* recalled by Wockhardt Usa | Wockhardt Usa | Manufacturing (CGMP) Deviations | Nationwide |