Hi-Tech Pharmacal HydrOXYzine Hydrochloride Oral Solution Recall

Why it was recalled

Subpotent; 24 month stability test station

Product description

HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16

Lot numbers, UPCs & expiration codes

Batch 608917 (exp. 02/2014), and Batch 608204 (exp. 01/2014)

Where it was sold

Nationwide and Puerto Rico

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-603-2013
Classification: Class III
Status: Terminated
Recall initiated: Apr 30, 2013
FDA report date: Jun 26, 2013
Quantity: lot 608917: 7764 bottles; lot 608204: 7476 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Hi-Tech Pharmacal Co., Inc.

Original FDA data

Every field from FDA enforcement report D-603-2013, exactly as published.

Show all FDA fields

City: Amityville
State: NY
Status: Terminated
Country: United States
Event ID: 65047
Address: 369 Bayview Ave
Code information: Batch 608917 (exp. 02/2014), and Batch 608204 (exp. 01/2014)
Postal code: 11701-2801
Report date: Jun 26, 2013
Product type: Drugs
Recall number: D-603-2013
Classification: Class III
Recalling firm: Hi-Tech Pharmacal Co., Inc.
Product quantity: lot 608917: 7764 bottles; lot 608204: 7476 bottles
Termination date: May 13, 2016
Reason for recall: Subpotent; 24 month stability test station
Voluntary / mandated: Voluntary: Firm initiated
Product description: HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16
Distribution pattern: Nationwide and Puerto Rico
Recall initiation date: Apr 30, 2013
Initial firm notification: Letter
Center classification date: Jun 14, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-603-2013, published Jun 26, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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