CLASS II Drug recall · Reported 15 Jun 2022 · FDA Enforcement Report
Earache Drops recalled by Grato Holdings
Grato Holdings is recalling Earache Drops, distributed nationwide in the US. The recall was initiated on 24 May 2022 and the FDA has classified it as Class II.
Check your package
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-0991-2022
- FDA event ID
- 90297
- Recalling firm
- Grato Holdings, Woodbine, IA
- Manufacturer
- Walgreen Company
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 May 2022
- FDA classified
- 8 Jun 2022
- Reported
- 15 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
Timeline
| 24 May 2022 | Recall initiated by company | |
| 8 Jun 2022 | Classified by FDA | +15 days |
| 15 Jun 2022 | 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
Microbial contamination of non-sterile product.
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
Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-3233-15
Where it was distributed
Nationwide within the USA
Questions about this recall
Is Earache Drops recalled?
Yes. Grato Holdings recalled Earache Drops on 24 May 2022. The recall is Class II and its status is Terminated. Recall number D-0991-2022.
Why was it recalled?
Microbial contamination of non-sterile product.
Which lots are affected?
Lot #: G11639, Exp. Date 09/24
Where was it sold?
Nationwide within the USA
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Drug | CLASS III | V-force Homeopathic recalled by Grato Holdings | Grato Holdings | Foreign Material | FL |
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