Novel Laboratories Recalls Hydrocodone Bitartrate and Homatropine Methylbromide Tablets
Novel Laboratories is recalling specific lots of Hydrocodone Bitartrate and Homatropine Methylbromide tablets due to failed impurities and degradation specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard involves failed impurities and degradation specifications, which is a quality control issue rather than a direct, immediate safety threat like a high-risk pathogen or structural defect.
Plain-English summary
Novel Laboratories, Inc. is recalling 134,364 bottles (4,030,920 tablets) of Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg. The product is manufactured by Novel Laboratories, Inc. in Somerset, NJ, and distributed nationwide. The recall involves specific lot codes including M16002A, M16246A, M16246B, M16434A, M16569A, M17015A, and S700271.
The recall was initiated because the product failed impurities and degradation specifications. This classification indicates that the product may not meet the required quality standards for safety and efficacy.
Consumers and healthcare providers should check their inventory for the specific lot codes listed above. If the product matches the recalled lots, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if they have been using the recalled medication.
The recalled product
- Product
- HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE)
- Brand
- HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
- Manufacturer
- Novel Laboratories, Inc.
- Category
- Drug — Prescription Medication
- Hazard
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 (7)
- M16002A (02/2018)
- M16246A (04/2018)
- M16246B (04/2018)
- M16434A (07/2018)
- M16569A (10/2018)
- M17015A (01/2019)
- S700271 (04/2019)
UPCs (2)
- 0343386118038
- 343386118038
Distribution
Distributed nationwide across the United States.
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