Cyclobenzaprine Hydrochloride Tablets 7.5mg Recalled for Microbial Contamination
Teva Pharmaceuticals is recalling Cyclobenzaprine Hydrochloride Tablets 7.5mg due to out-of-specification microbial counts in an ingredient batch. The product was distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a manufacturing quality deviation (out-of-specification microbial contamination in an excipient). The source text does not report any illnesses, hospitalizations, or injuries, and the contamination was detected during quality control testing before widespread harm could occur.
Plain-English summary
Teva Pharmaceuticals USA is recalling Cyclobenzaprine Hydrochloride Tablets, 7.5mg (100 count bottles, NDC 0591-3330-01, lot 1408821A with expiration date 08/2023) due to a Current Good Manufacturing Practice (CGMP) deviation involving an ingredient used in the product.
The Dibasic Calcium Phosphate excipient batch used in this drug failed quality testing, showing out-of-specification results for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC).
Approximately 9,655 bottles were distributed nationwide. Consumers currently taking this medication should contact their healthcare provider or pharmacist before stopping use to discuss alternatives or next steps.
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, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3330-01
- Manufacturer
- Teva Pharmaceuticals USA
- Hazard
- microbial-contamination
- manufacturing-deviation
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)
- 1408821A
- exp. date 08/2023 (labeler - Teva)
Distribution
Distributed nationwide across the United States.
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