Use caution Drug recall · FDA · Published May 21, 2013

American Health Packaging Recalls Zolpidem Tartrate Due to Mispackaging

American Health Packaging recalls Zolpidem Tartrate Tablets 5 mg due to unit dose mispackaging that may result in extra tablets per blister. Check lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-856-2013Drug American Health Packaging ›

Use caution until it’s fixed

Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet.

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 Zolpidem Tartrate Tablets 5 mg because of a packaging error where some blisters may contain more than one tablet instead of the intended single dose. This affects specific lots distributed nationwide with expiration dates ranging from June 2014 to February 2015. The recall was initiated on May 21, 2013. Read more at govinfonow.com/recall/47889-american-health-packaging-recalls-zolpidem-tartrate-tablets-5-mg-10.

Source Summary by GovInfoNow · govinfonow.com/recall/47889-american-health-packaging-recalls-zolpidem-tartrate-tablets-5-mg-10 · Updated October 13, 2026 · FDA enforcement record: FDA #D-856-2013

Cite this page

“American Health Packaging Recalls Zolpidem Tartrate Due to Mispackaging.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/47889-american-health-packaging-recalls-zolpidem-tartrate-tablets-5-mg-10. Based on FDA recall #D-856-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-856-2013%22&limit=1).

The FDA announced on May 21, 2013, that American Health Packaging voluntarily recalled Zolpidem Tartrate Tablets 5 mg due to a unit dose mispackaging hazard. The agency said the issue could result in blisters containing more than one tablet.

How to tell if you have it

Brand: American Health Packaging
Product: Zolpidem Tartrate Tablets 5 mg
NDC: 68084-225-01
Lot codes: 114215, 114216, 114217, 120087, 120295, 121573, 123572, 123983, 130071
Expiration dates: 7/13, 9/13, 6/14, 9/14, 2/15
Quantity: 48,230 carton units

The hazard

The FDA said the recall is due to a random undetected packaging issue that could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet.

Context

GovInfoNow's records show American Health Packaging has 41 other recalls on record since July 23, 2012. Other recent recalls include an August 19, 2026 label mix-up for Buprenorphine Tablets, a May 3, 2022 dissolution failure for Nitrofurantoin Capsules, and an April 12, 2022 subpotent drug issue with Cyanocobalamin Injection. Other recent recalls of similar products include Preferred Pharma's November 17, 2025 Ondansetron ODT recall due to defective seals, Unichem's January 21, 2026 Bisoprolol/Hydrochlorothiazide Tablets recall for N-Nitroso impurity risk, and Asclemed's May 14, 2026 Duloxetine Capsules recall for nitrosamine impurity risk.

How to tell if you have this one

Check your medication box for NDC 68084-225-01 and look at the lot numbers on the label. Affected lots are: 114215 (Exp 7/13), 114216 (Exp 7/13), 114217 (Exp 7/13), 120087 (Exp 9/13), 120295 (Exp 9/13), 121573 (Exp 6/14), 123572 (Exp 9/14), 123983 (Exp 9/14), and 130071 (Exp 2/15). The product is manufactured for Wockhardt USA LLC in Parsippany, NJ.

Brand
American Health Packaging
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Medication
Verify if your Zolpidem Tartrate Tablets 5 mg match the affected lot numbers and expiration dates listed above.
Contact Your Pharmacist
If you have an affected lot, contact your pharmacy or healthcare provider to discuss returning the product or obtaining a replacement.

Where it went and when

Where it was distributed

Distributed nationwide.

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 7 months after the firm started it.

May 21, 2013Firm started the recall
Aug 8, 2013FDA classified it Class II
Aug 14, 2013Published in FDA’s Enforcement Report
Dec 24, 2013FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Who is manufacturing this product?

The product is manufactured for Wockhardt USA LLC by Wockhardt Limited in Mumbai, India.

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Link to this recall

<a href="https://govinfonow.com/recall/47889-american-health-packaging-recalls-zolpidem-tartrate-tablets-5-mg-10">American Health Packaging Recalls Zolpidem Tartrate Due to Mispackaging (GovInfoNow)</a>

Where this comes from

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-856-2013 (May 21, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-856-2013 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.