# FDA recall D-0775-2021

> **Teva Pharmaceuticals USA** · Class II · drug recall initiated 2021-07-29.

## Product

Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01

## Reason for recall

CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC)  for an excipient batch of Dibasic Calcium Phosphate.

## Distribution

Product was distributed nationwide.

## Key facts

- **Recall number:** D-0775-2021
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-07-29
- **Report date:** 2021-09-08
- **Termination date:** 2022-11-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0775-2021

## Citation

> AI Analytics. FDA recall D-0775-2021. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-0775-2021. Source: US FDA. Licensed CC0.

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