Ameridose Recalls Non-Sterile Drug Products Due to GMP Deficiencies
Ameridose LLC is voluntarily recalling all non-sterile products nationwide due to Good Manufacturing Practice (GMP) deficiencies. The recall was initiated in October 2012.
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: The recall is classified as FDA Class II and is voluntary, with no reported illnesses or injuries in the source text, fitting the criteria for a moderate severity score.
Plain-English summary
Ameridose LLC, located in Westborough, Massachusetts, has voluntarily recalled all non-sterile products manufactured by the company. The recall was initiated on October 31, 2012, and covers all lot codes within their expiration dates. A complete list of the specific products subject to this recall is available online at www.ameridose.com.
The reason for the recall is cited as Good Manufacturing Practice (GMP) deficiencies. The FDA classified this recall as Class II, which indicates a situation that may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The recall is distributed nationwide.
Consumers and healthcare providers should check the Ameridose website for the specific list of affected products. The recall status is currently terminated, with a termination date of July 25, 2016.
The recalled product
- Product
- All Non-Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com
- Manufacturer
- Ameridose LLC
- Category
- Drug — Non-Sterile Products
- 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 (1)
- All lot codes within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ameridose LLC 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Ameridose LLC
See all →- SevereAmeridose Recalls All Sterile Products Due to Sterility Assurance Concerns
FDA (Drugs) · 2012-11-21
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