CLASS III Drug recall · Reported 22 Jul 2015 · FDA Enforcement Report
HydrOXYzine Hydrochloride Tablets, USP 25 mg recalled
Qualitest Pharmaceuticals is recalling HydrOXYzine Hydrochloride Tablets, USP 25 mg, distributed nationwide in the US. The recall was initiated on 29 Jun 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-1239-2015
- FDA event ID
- 71646
- Recalling firm
- Qualitest Pharmaceuticals, Huntsville, AL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 29 Jun 2015
- FDA classified
- 15 Jul 2015
- Reported
- 22 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Anxiety & Sleep Medication
Timeline
| 29 Jun 2015 | Recall initiated by company | |
| 15 Jul 2015 | Classified by FDA | +16 days |
| 22 Jul 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
Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
Product as listed by the FDA
HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
Which lots are affected?
100 count (NDC 0603-3968-21); LOTS# T144F13A, T130G13B, T132G13A, exp date 6/15, T115D14A, exp date 3/16; 500 count (NDC 0603-3968-28), LOT# T144F13B exp date 6/15; and 1000 count (NDC 0603-3968-32); LOTS # T144F13C, T132G13B, exp date 6/15, T115D14B, exp date 3/16
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.
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|---|---|---|---|---|---|
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| Drug | CLASS II | Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg recalled | Morton Grove Pharmaceuticals | Potency & Assay | Nationwide |
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