Use cautionDrug recall · FDA · Published January 31, 2014
American Health Packaging Recalls HydrOXYzine HCl Tablets Due to GMP Deviations
American Health Packaging recalls 14,665 blister packs of HydrOXYzine HCl Tablets (25 mg) due to Good Manufacturing Practices deviations involving an unapproved active ingredient source.
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Take action
Contact the company
📍Recalling firmAmerican Health Packaging2550 John Glenn Ave, Suite A · Columbus, OH 43217-1188
✎ GovInfoNow plain-language explainer
American Health Packaging is recalling HydrOXYzine HCl Tablets, USP 25 mg because the product contains an active pharmaceutical ingredient from an unapproved source. This constitutes a deviation from Good Manufacturing Practices. The recall affects 14,665 blister packs distributed nationwide. Read more at govinfonow.com/recall/46275-american-health-packaging-recalls-hydroxyzine-hcl-tablets-usp-25-mg.
“American Health Packaging Recalls HydrOXYzine HCl Tablets Due to GMP Deviations.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/46275-american-health-packaging-recalls-hydroxyzine-hcl-tablets-usp-25-mg. Based on FDA recall #D-1188-2014 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1188-2014%22&limit=1).
The FDA announced on Jan. 31, 2014, that American Health Packaging voluntarily recalled HydrOXYzine HCl Tablets due to Good Manufacturing Practices deviations involving an unapproved active pharmaceutical ingredient source.
According to the FDA, the product contains an active pharmaceutical ingredient from an unapproved source. This constitutes a deviation from Good Manufacturing Practices.
Context
GovInfoNow's records show American Health Packaging has had 41 other recalls on record since July 23, 2012. Other recent recalls of similar products include American Health Packaging Buprenorphine Tablets Recall (Aug. 19, 2026), American Health Packaging Nitrofurantoin Capsules Recall (May 3, 2022), and American Health Packaging Recalls Cyanocobalamin Injection (April 12, 2022). Other recent recalls of similar products include ANI Pharmaceuticals recalls hydrOXYzine oral solution (June 2, 2026), Ajanta Pharma Fenofibrate Capsules Recall (May 28, 2026), and Meclizine 12.5mg Tablets Recall (March 16, 2026).
How to tell if you have this one
Check if you have HydrOXYzine HCl Tablets, USP 25 mg in a 100-tablet blister pack manufactured by KVK-TECH, INC. Look for NDC 68084-254-01 and one of the following lot numbers with their corresponding expiration dates: Lot 120407 (Exp 01/14), Lot 121337 (Exp 03/14), Lot 122054 (Exp 05/14), Lot 122598 (Exp 06/14), or Lot 130125 (Exp 12/14).
Brand
American Health Packaging
Category
Drug
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Nationwide
Recall number
Product, codes & lots
Quantity
D-1188-2014
HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01; Lot 120407, Exp 01/14; Lot 121337 Exp 03/14; Lot 122054, Exp 05/14; Lot 122598, Exp 06/14; Lot 130125, Exp 12/14
14,665 blister packs
D-1189-2014
HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01; Lot 120757, Exp. 02/14; Lot 121104, Exp 03/14; Lot 122055, Exp 05/14; Lot 123038, Exp 07/14; Lot 125115, Exp 11/14
8,570 blister packs
Based on the official FDA remedy
What to do — step by step
Check Your Medication
Verify if your HydrOXYzine HCl Tablets match the recalled lot numbers and expiration dates listed in the record.
Contact Your Pharmacist
Speak with your pharmacist or healthcare provider immediately to discuss alternative treatment options since no specific remedy is stated in the record.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-1188-2014 (January 31, 2014) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1188-2014 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.