CLASS II Drug recall · Reported 20 Jun 2018 · FDA Enforcement Report
Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg recalled
RIJ Pharmaceutical is recalling Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg, distributed nationwide in the US. The recall was initiated on 7 May 2018 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-0846-2018
- FDA event ID
- 80053
- Recalling firm
- RIJ Pharmaceutical, Middletown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 May 2018
- FDA classified
- 8 Jun 2018
- Reported
- 20 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 7 May 2018 | Recall initiated by company | |
| 8 Jun 2018 | Classified by FDA | +32 days |
| 20 Jun 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL, packaged in 16 FL OZ (473 mL), Dist. By Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204, NDC 5789618016, UPC 357896180164
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg recalled?
Yes. RIJ Pharmaceutical recalled Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg on 7 May 2018. The recall is Class II and its status is Terminated. Recall number D-0846-2018.
Why was it recalled?
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Which lots are affected?
Lot #: 47080081, 47080093, Exp. 08/19
Where was it sold?
Nationwide in 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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