Medications & Supplements/Prescription Drugs

Teva, Casper, and Rising Cyclobenzaprine Recalled for Microbial Contamination

Agency Publication Date: August 27, 2021

Summary

Teva Pharmaceuticals USA is recalling 19,234 bottles of Cyclobenzaprine Hydrochloride (7.5mg) tablets, a prescription muscle relaxant. The recall affects product sold under the Teva, Casper, and Rising labels because a specific ingredient tested outside of acceptable limits for bacterial, yeast, and mold counts. No incidents or injuries have been reported to date regarding this issue.

Risk

The tablets may contain higher than acceptable levels of microbes, yeast, or mold due to a contaminated ingredient. Consuming contaminated medication could lead to infections or other health risks, especially for individuals with weakened immune systems.

What You Should Do

This recall affects Cyclobenzaprine Hydrochloride Tablets (7.5mg) in 100-count bottles sold under the Teva, Casper, and Rising brands with expiration dates of August 2023.
Identify the affected products by looking for lot numbers 1408821A (Teva label, NDC 0591-3330-01), 1408822A (Casper label, NDC 70199-014-01), or 1408824A (Rising label, NDC 57237-266-01).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Cyclobenzaprine Hydrochloride Tablets (100 count)by Teva / Actavis

Variants: 7.5mg, Tablet

Model:

D-0774-2021

Lot Numbers:

1408821A (Exp 08/2023)

NDC:

0591-3330-01

Distributed by Actavis Pharma, Inc.

Product: Cyclobenzaprine Hydrochloride Tablets (100 count)by Casper

Variants: 7.5mg, Tablet

Model:

D-0775-2021

Lot Numbers:

1408822A (Exp 08/2023)

NDC:

70199-014-01

Product: Cyclobenzaprine Hydrochloride Tablets (100 count)by Rising

Variants: 7.5mg, Tablet

Model:

D-0776-2021

Lot Numbers:

1408824A (Exp 08/2023)

NDC:

57237-266-01

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88370

Status: Resolved

Manufacturer: Teva Pharmaceuticals USA

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 3 products (9,655 bottles; 4,587 bottles; 4,992 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Cyclobenzaprine Hydrochloride Tablets (7.5mg) in 100-count bottles sold under the Teva, Casper, and Rising brands with expiration dates of August 2023.

Identify the affected products by looking for lot numbers 1408821A (Teva label, NDC 0591-3330-01), 1408822A (Casper label, NDC 70199-014-01), or 1408824A (Rising label, NDC 57237-266-01).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Cyclobenzaprine Hydrochloride Tablets (100 count)by Teva / Actavis

Variants: 7.5mg, Tablet

Model:

D-0774-2021

Lot Numbers:

1408821A (Exp 08/2023)

NDC:

0591-3330-01

Distributed by Actavis Pharma, Inc.

Product: Cyclobenzaprine Hydrochloride Tablets (100 count)by Casper

Variants: 7.5mg, Tablet

Model:

D-0775-2021

Lot Numbers:

1408822A (Exp 08/2023)

NDC:

70199-014-01

Product: Cyclobenzaprine Hydrochloride Tablets (100 count)by Rising

Variants: 7.5mg, Tablet

Model:

D-0776-2021

Lot Numbers:

1408824A (Exp 08/2023)

NDC:

57237-266-01