Cyclobenzaprine Hydrochloride Tablets — Class II drug recall D-0775-2021
Terminated recall by Teva Pharmaceuticals USA, reported 2021-09-08, distributed nationwide. CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yea
| Recall number | D-0775-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Parsippany, NJ, United States |
| Recall initiated | 2021-07-29 |
| Classified | 2021-08-27 |
| Reported by FDA | 2021-09-08 |
| Terminated | 2022-11-04 |
| Distributed | Nationwide (US) |
| Quantity | 4,587 bottles |
| Reason classes | microbial contamination, cgmp, specification failure |
| Pathogens | mold, yeast |
| NDC | 70199-0014-01 |
| Expiration dates | 2023-08 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0775-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.