Virtus Pharmaceuticals Opco Ii L Hyoscyamine Sulfate Recall

Why it was recalled

Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.

Product description

Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10.

Lot numbers, UPCs & expiration codes

Lot #: 30011601, Exp 01/18

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-0213-2017
Classification: Class I
Status: Terminated
Recall initiated: Sep 2, 2016
FDA report date: Dec 28, 2016
Quantity: 10,572 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: VIRTUS PHARMACEUTICALS OPCO II L

Original FDA data

Every field from FDA enforcement report D-0213-2017, exactly as published.

Show all FDA fields

City: Nashville
State: TN
Status: Terminated
Country: United States
Event ID: 75146
Address: 1321 Murfreesboro Pike #
Code information: Lot #: 30011601, Exp 01/18
Postal code: 37217-2726
Report date: Dec 28, 2016
Product type: Drugs
Recall number: D-0213-2017
Classification: Class I
Recalling firm: VIRTUS PHARMACEUTICALS OPCO II L
Product quantity: 10,572 bottles
Termination date: Sep 23, 2019
Reason for recall: Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10.
Distribution pattern: Nationwide and Puerto Rico
Recall initiation date: Sep 2, 2016
Initial firm notification: E-Mail
Center classification date: Dec 22, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0213-2017, published Dec 28, 2016. 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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