Nandrolone Decanoate USP Recalled for Lack of Stability Data
American Pharmaceutical Ingredients LLC is recalling Nandrolone Decanoate USP for prescription compounding due to a lack of stability data supporting expiration dates.
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, which corresponds to a moderate severity score of 2 under the rubric for minor labeling or documentation issues where the risk is theoretical and no illnesses are reported.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Nandrolone Decanoate USP for prescription compounding. The product is available in 25g, 100g, 500g, and 1000g packages and is distributed nationwide within the USA. The total quantity involved is 86,225 g.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacked the necessary stability data and controls to support the assigned retest or expiration dates for the product in its container/closure system.
This recall affects pharmacies and compounding facilities that may have received the affected lots. Consumers should not use the product and should contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- Nandrolone Decanoate USP for prescription compounding, packaged in a) 25g (NDC 58597-0081-4); b) 100g (NDC 58597-0081-6); c) 500g (NDC 58597-0081-7); d) 1000g (NDC 58597-0081-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
- Affected units
- 86,225
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 (15)
- Lot #: a) 012716-1
- 012716-2
- Exp. 01/12/2019
- 110316-3
- Exp. 09/21/2021 b) 012716-1
- 012716-3
- 110316-1
- Exp. 09/21/2021
- c) 012716-1
- 110316-2
- exp. 09/21/2021
- d) 012716-1
- 041717-2
- Exp. 04/06/2022
- Exp. 09/21/2021.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 66 recalled by American Pharmaceutical Ingredients 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 66 products in this recall →Related recalls
Same manufacturer · American Pharmaceutical Ingredients LLC
See all →- ModerateAmerican Pharmaceutical Ingredients Recalls Sermorelin Acetate Powder Due to Stability Data
FDA (Drugs) · 2018-03-21
- ModerateOxytocin USP Powder Recalled Due to Insufficient Stability Data
FDA (Drugs) · 2018-03-21
- ModerateFDA Recalls Testosterone Cypionate Due to Missing Stability Data
FDA (Drugs) · 2018-02-28
- ModerateLevofloxacin Hemihydrate Recalled for Lack of Stability Data
FDA (Drugs) · 2018-02-28
- ModerateFDA Recalls Doxycycline Hyclate Due to Missing Stability Data
FDA (Drugs) · 2018-02-28
Same hazard · documentation issue
See all →- LowHeartSine Defibrillators Recalled for Missing Maintenance Supplement
FDA (Devices) · 2026-10-07
- SevereBMC Medical Luna G3 APAP Devices Recalled for Retroactive Rework Reporting
FDA (Devices) · 2026-08-26
- LowFARASTAR Cardiac Ablation Generator Recall for Missing Catheter Information
FDA (Devices) · 2026-07-29
- ModerateFARASTAR Ablation Generator EU Medical Device Recall for Labeling Discrepancy
FDA (Devices) · 2026-07-29
- LowPenner bathing spa models recalled for lacking a unique device identifier
FDA (Devices) · 2026-03-18
Similar recalls
- ModeratePrescription Compounding Drug Nandrolone Decanoate Recalled for Subpotency
FDA (Drugs) · 2022-05-18
- ModerateFDA recalls Nandrolone Decanoate compounding ingredient for subpotency nationwide
FDA (Drugs) · 2022-05-18
- ModerateOxytocin USP Powder Recalled Due to Insufficient Stability Data
FDA (Drugs) · 2018-03-21
- ModerateAmerican Pharmaceutical Ingredients Recalls Estrone USP Due to cGMP Deviations
FDA (Drugs) · 2017-06-21
- ModerateFagron recalls Nandrolone Decanoate USP for subpotency in multiple lots
FDA (Drugs) · 2022-05-18
- ModerateFDA Recalls Subpotent Nandrolone Decanoate Compounding Ingredient from Fagron
FDA (Drugs) · 2022-05-18