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.
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 2/5 (Moderate).
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
- Affected units
- 9,655
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.
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.
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