CLASS III Drug recall · Reported 16 Sep 2015 · FDA Enforcement Report
Imipramine HCl Tablets, USP, 25 mg recalled
Mutual Pharmaceutical Company is recalling Imipramine HCl Tablets, USP, 25 mg, distributed nationwide in the US. The recall was initiated on 16 Jul 2015 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-1424-2015
- FDA event ID
- 71836
- Recalling firm
- Mutual Pharmaceutical Company, Philadelphia, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 16 Jul 2015
- FDA classified
- 9 Sep 2015
- Reported
- 16 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 16 Jul 2015 | Recall initiated by company | |
| 9 Sep 2015 | Classified by FDA | +55 days |
| 16 Sep 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Chemical Contamination; benzophenone leached from the product label varnish
Product as listed by the FDA
Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-913-01
Where it was distributed
Nationwide
Questions about this recall
Is Imipramine HCl Tablets, USP, 25 mg recalled?
Yes. Mutual Pharmaceutical Company recalled Imipramine HCl Tablets, USP, 25 mg on 16 Jul 2015. The recall is Class III and its status is Terminated. Recall number D-1424-2015.
Why was it recalled?
Chemical Contamination; benzophenone leached from the product label varnish
Which lots are affected?
lot #s: 6655001, exp 8/16, 6679801, exp 2/17, 6690302, exp 4/17 and 6706001, exp 7/17
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 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 Mutual Pharmaceutical Company
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sulfamethoxazole and Trimethoprim Tablets recalled | Mutual Pharmaceutical Company | Other | MS |
| Drug | CLASS III | Imipramine HCl Tablets, USP, 10 mg recalled | Mutual Pharmaceutical Company | Other | Nationwide |
| Drug | CLASS III | Imipramine HCl Tablets, USP, 50 mg recalled | Mutual Pharmaceutical Company | Other | Nationwide |
| Drug | CLASS III | Felodipine Extended-Release Tablets, 5 mg recalled | Mutual Pharmaceutical Company | Other | Nationwide |
| Drug | CLASS III | Felodipine Extended-Release Tablets, 10 mg recalled | Mutual Pharmaceutical Company | Other | Nationwide |
Other Imipramine recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Imipramine HCl Tablets, USP, 10 mg recalled | Mutual Pharmaceutical Company | Other | Nationwide |
| Drug | CLASS III | Imipramine HCl Tablets, USP, 50 mg recalled | Mutual Pharmaceutical Company | Other | Nationwide |