Synthetopes Recalls Pentreotide Vials Due to Lack of Processing Controls
Synthetopes Inc. is recalling Pentreotide (10 uGm) vials nationwide due to a lack of processing controls. All lots remaining within expiry are affected.
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: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or specific high-risk pathogens, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Synthetopes Inc. is recalling Pentreotide (10 uGm), Not for Direct Injection, manufactured by Synthetopes Inc. The recall involves 20 vials per package. The product was distributed nationwide.
The reason for the recall is a lack of processing controls. All lots remaining within their expiry date are included in this recall.
Consumers should stop using the product and contact Synthetopes Inc. for further instructions or a refund.
The recalled product
- Product
- Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc.
- Manufacturer
- Synthetopes Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 20
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 lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Synthetopes Inc 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 8 products in this recall →Related recalls
Same manufacturer · Synthetopes Inc
See all →- SevereSynthetopes Recalls Sn-d, l-Exametazime Due to Lack of Processing Controls
FDA (Drugs) · 2019-06-19
- SevereSynthetopes Recalls Sn-Tetrofosmin Kits Due to Processing Control Deficiencies
FDA (Drugs) · 2019-06-19
- ModerateSynthetopes Recalls Sn-DTPA Kit Due to Lack of Processing Controls
FDA (Drugs) · 2019-06-19
- ModerateSynthetopes Recalls Sn-Mertiatide Kit Due to Processing Control Deficiencies
FDA (Drugs) · 2019-06-19
- ModerateSynthetopes Recalls Sulfur Colloid Reaction Vials Due to Processing Controls
FDA (Drugs) · 2019-06-19
Same hazard · processing controls
See all →- HighCompounded tirzepatide 8.8 mg vials recalled over lack of processing controls
FDA (Drugs) · 2025-08-13
- HighCompounded tirzepatide 11.24 mg vials recalled over lack of processing controls
FDA (Drugs) · 2025-08-13
- HighCompounded semaglutide 0.22 mg vials recalled over lack of processing controls
FDA (Drugs) · 2025-08-13
- HighCompounded semaglutide 0.44 mg vials recalled over lack of processing controls
FDA (Drugs) · 2025-08-13
- HighCompounded tirzepatide 4.4 mg vials recalled over lack of processing controls
FDA (Drugs) · 2025-08-13
Similar recalls
- ModerateWise Pharmacy Recalls Papaverine/Phentolamine Injectable Due to Processing Controls
FDA (Drugs) · 2019-08-07
- HighFDA Recalls Papaverine/Phentolamine Injectable Vials Due to Sterility Concerns
FDA (Drugs) · 2023-02-01
- HighPhentolamine Injectable Drug Recalled Due to Sterility Concerns
FDA (Drugs) · 2022-11-09
- SevereInfusion Options Recalls Methylprednisolone Due to Sterility Concerns
FDA (Drugs) · 2019-08-21
- ModerateAmneal Recalls Extended Phenytoin Sodium Capsules Due to Dissolution Failure
FDA (Drugs) · 2013-11-13
- CriticalOctreotide Acetate Injection Recalled for Glass Particle Contamination
FDA (Drugs) · 2022-11-16