CLASS II Drug recall · Reported 25 Nov 2015 · FDA Enforcement Report
HCG (Lyophilized) Injectable vial recalled by Downing Labs
Downing Labs is recalling HCG (Lyophilized) Injectable vial, distributed nationwide in the US. The recall was initiated on 16 Oct 2015 and the FDA has classified it as Class II.
Check your package
Lot, batch or date codes All lots
Quantity recalled 1062 vials
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
Recall number D-0355-2016
FDA event ID 72455
Classification Class II
Status Terminated
Recall initiated 16 Oct 2015
FDA classified 18 Nov 2015
Reported 25 Nov 2015
Type Voluntary: Firm initiated
Customers notified by Press Release
Timeline
16 Oct 2015 Recall initiated by company 18 Nov 2015 Classified by FDA +33 days 25 Nov 2015 Published in enforcement report +7 days
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
HCG (Lyophilized) Injectable, 5000 units/vial, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Where it was distributed
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan
Nationwide
Questions about this recall
Why was it recalled? Lack of Assurance of Sterility
Which lots are affected? All lots
Where was it sold? Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan
What should I do if I have it? Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean? Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event 47 other products · FDA event 72455 This product is part of a recall event; the main page for the event is L-Tryptophan Injectable, 30mg/mL vial recalled by Downing Labs .
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