Agency classClass IIOur severity:High FDA (Drugs)·D-0776-2021·Announced 2021-09-08

Cyclobenzaprine Hydrochloride Tablets 7.5mg Recalled for Microbial Contamination

Teva Pharmaceuticals USA is recalling Cyclobenzaprine Hydrochloride Tablets 7.5mg (4,992 bottles, batch 1408824A, expiration 08/2023) distributed nationwide due to out-of-specification microbial test results in an excipient ingredient.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with a manufacturing defect (microbial contamination via out-of-specification test results). No reported illnesses or injuries are stated in the source text, but the hazard is real rather than theoretical—excipient contamination in a systemically administered tablet poses an inherent risk of harm. Under the rubric, the absence of reported illness in a Class II recall with potential for harm qualifies as High severity.

Plain-English summary

Teva Pharmaceuticals USA is recalling Cyclobenzaprine Hydrochloride Tablets 7.5mg, 100-count bottles (NDC 57237-266-01, manufactured by Actavis Laboratories FL, Inc.) due to Current Good Manufacturing Practice (CGMP) deviations.

The recall was initiated because an excipient batch of Dibasic Calcium Phosphate tested out of specification for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC). This indicates potential microbial contamination in the manufacturing ingredient.

Approximately 4,992 bottles with batch code 1408824A and expiration date 08/2023 (labeler: Rising) were distributed nationwide. Patients currently taking this medication should consult their healthcare provider or pharmacist before discontinuing use or seeking alternative treatments.

The recalled product

Product: Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 57237-266-01
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Muscle Relaxant
Hazard: microbial-contamination
cgmp-deviation
Affected units: 4,992

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

1408824A
exp. date 08/2023 (labeler - Rising)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · microbial contamination