CLASS III Drug recall · Reported 9 Apr 2025 · FDA Enforcement Report
Tolterodine Tartrate Extended-Release Capsules, 2 mg Dose recalled
The Harvard Drug Group is recalling Tolterodine Tartrate Extended-Release Capsules, 2 mg Dose, distributed nationwide in the US. The recall was initiated on 4 Mar 2025 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-0304-2025
- FDA event ID
- 96416
- Recalling firm
- The Harvard Drug Group, La Vergne, TN
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 Mar 2025
- FDA classified
- 28 Mar 2025
- Reported
- 9 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Bladder & Prostate Medication
Timeline
| 4 Mar 2025 | Recall initiated by company | |
| 28 Mar 2025 | Classified by FDA | +24 days |
| 9 Apr 2025 | Published in enforcement report | +12 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: Out of specification results obtained during routine stability testing for dissolution.
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
Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Which lots are affected?
Lot# T05393, Exp. Date: 09/30/2025
Where was it sold?
Nationwide in the USA
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 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 The Harvard Drug Group
All 79| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carton Label: Major, Methylergonovine Maleate Tablets recalledMethylergonovine Maleate | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Omega-3-Acid, Ethyl Esters, Capsules recalled by The Harvard Drug GroupOmega-3-acid Ethyl Esters | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Memantine Hydrochloride Extended-Release, Capsules, 7 mg recalledMemantine Hydrochloride | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Midodrine Hydrochloride Tablets, USP, 5 mg ( blister packs) recalledMidodrine Hydrochloride | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg ( blister packs) recalledGabapentin | The Harvard Drug Group | Potency & Assay | Nationwide |
Other Tolterodine recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Tolterodine Tartrate Tablets, 1 mg recalled by Mylan Pharmaceuticals | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Tolterodine Tartrate ER, Capsule, 2 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Tolterodine Tartrate ER, Capsule, 4 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |