West-Ward Pharmaceutical VersaPharm Incorporated Recall

Why it was recalled

Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink.

Product description

VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA 30065-1509; Mfd. by: West-ward Pharmaceuticals Corp., Eatontown, NJ 07724 NDC 61748-014-06,

Lot numbers, UPCs & expiration codes

Lot 69968B 03/14

Where it was sold

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-839-2013
Classification: Class II
Status: Terminated
Recall initiated: Jun 4, 2013
FDA report date: Aug 14, 2013
Quantity: 118 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: West-Ward Pharmaceutical Corp.

Original FDA data

Every field from FDA enforcement report D-839-2013, exactly as published.

Show all FDA fields

City: Eatontown
State: NJ
Status: Terminated
Country: United States
Event ID: 65582
Address: 465 Industrial Way W
Code information: Lot 69968B 03/14
Postal code: 07724-2209
Report date: Aug 14, 2013
Product type: Drugs
Recall number: D-839-2013
Classification: Class II
Recalling firm: West-Ward Pharmaceutical Corp.
Product quantity: 118 bottles
Termination date: Jun 5, 2014
Reason for recall: Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink.
Voluntary / mandated: Voluntary: Firm initiated
Product description: VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA 30065-1509; Mfd. by: West-ward Pharmaceuticals Corp., Eatontown, NJ 07724 NDC 61748-014-06,
Distribution pattern: GA
Recall initiation date: Jun 4, 2013
Initial firm notification: Letter
Center classification date: Aug 2, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-839-2013, published Aug 14, 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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