Sandoz Recalls Amitriptyline Hydrochloride Tablets Due to Cross-Contamination
Sandoz Incorporated is recalling specific lots of Amitriptyline Hydrochloride 25 mg tablets because they were cross-contaminated with Imipramine.
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 FDA classified this as a Class III recall, which indicates the product is not likely to cause adverse health consequences. The hazard is cross-contamination with another drug, which is a labeling/quality issue rather than a high-risk pathogen or structural defect.
Plain-English summary
Sandoz Incorporated is recalling 38,234 bottles of Amitriptyline Hydrochloride Tablets, USP 25 mg. The affected products are packaged in 100-count bottles (NDC 0781-1487-01) and 1000-count bottles (NDC 0781-1487-10). The specific lots involved are GR3831 and GS9690 (expiration 08/2019) for the 100-count bottles, and GR3832 (expiration 08/2019) for the 1000-count bottles.
The recall was initiated because the product was cross-contaminated with Imipramine. This is a prescription-only medication manufactured by Sandoz Inc. in Princeton, NJ, and distributed throughout the United States.
Consumers and healthcare providers should check their inventory for the specific NDCs and lot numbers listed above. If the product matches the recalled description, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE)
- Brand
- AMITRIPTYLINE HYDROCHLORIDE
- Manufacturer
- Sandoz Incorporated
- Category
- Drug — Prescription Medication
- Affected units
- 38,234
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 (5)
- Lot #: a) GR3831
- GS9690
- Exp. 08/2019
- b) GR3832
- Exp. 08/2019.
Distribution
Distribution scope not specified by the agency.
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