CLASS III Drug recall · Reported 11 Jan 2017 · FDA Enforcement Report
Temazepam Capsules USP, 7.5 mg recalled by Vintage Pharmaceuticals LLC
Vintage Pharmaceuticals LLC is recalling Temazepam Capsules USP, 7.5 mg, distributed nationwide in the US. The recall was initiated on 22 Dec 2016 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-0326-2017
- FDA event ID
- 76087
- Recalling firm
- Vintage Pharmaceuticals LLC, Huntsville, AL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 Dec 2016
- FDA classified
- 3 Jan 2017
- Reported
- 11 Jan 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Anxiety & Sleep Medication
Timeline
| 22 Dec 2016 | Recall initiated by company | |
| 3 Jan 2017 | Classified by FDA | +12 days |
| 11 Jan 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability 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
TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-5891-21
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Stability Specifications
Which lots are affected?
T248H15A, Exp. 08/17
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 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 Vintage Pharmaceuticals LLC
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Hydrocortisone Lotion recalled by Vintage Pharmaceuticals LLC | Vintage Pharmaceuticals LLC | Potency & Assay | Nationwide |
| Drug | CLASS II | Hydrochlorothiazide Capsules, USP, 12.5 mg recalled | Vintage Pharmaceuticals LLC | Particulate Matter | Nationwide |
| Drug | CLASS III | Ranitidine Syrup (Ranitidine Oral Solution, USP) 15 mg/mL (75 mg recalled | Vintage Pharmaceuticals LLC | Potency & Assay | Nationwide |
| Drug | CLASS III | Ampicillin Capsules, USP, 250 mg recalled by Vintage Pharmaceuticals LLC | Vintage Pharmaceuticals LLC | Packaging Defects | OH |
Other Temazepam recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Temazepam, Capsule, 7.5 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |