Severity
Moderate
ModerateClass IIOngoing
FDA Drug recall · Reported October 13, 2021
Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01
Labeling: Incorrect Instructions
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Rising Pharmaceuticals recalled Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising P… - a moderate-severity action.
Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising P… was recalled by Rising Pharmaceuticals in October 13, 2021. Reason: Labeling: Incorrect Instructions. Check the official notice for the remedy. Verify recall #D-0005-2022 with the FDA Drug before acting.
The recall
Rising Pharmaceuticals issued this moderate-severity FDA Drug recall-Labeling: Incorrect Instructions.
- Moderate
- severity level
- Class II
- classification
- October 13, 2021
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0005-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0005-2022) was formally reported on October 13, 2021, with the manufacturer initiating the action on September 2, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Rising Pharmaceuticals is listed as the recalling firm, operating out of East Brunswick, NJ. Federal records list the affected scope as 1,344 bottles.
The documented reason for this recall is: Labeling: Incorrect Instructions Distribution data in the federal record shows the product reached: to be entered. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,344 bottles
Related Recalls
6
0 from same agency
Product description
Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01
Reason for recall
Labeling: Incorrect Instructions
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0005-2022 |
| Date reported | October 13, 2021 |
| Date initiated | September 2, 2021 |
| Recalling firm | Rising Pharmaceuticals |
| Firm location | East Brunswick, NJ |
| Affected scope | 1,344 bottles |
| Distribution | to be entered |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0005-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01. Recalled by Rising Pharmaceuticals. Units affected: 1,344 bottles.
Why was this product recalled? ▼
Labeling: Incorrect Instructions
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 13, 2021. Severity: Moderate. Recall number: D-0005-2022.
Where was the recalled product distributed? ▼
Distribution: to be entered.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0005-2022) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
AMASKY Nursing Pillows Recalled Due to Risk of Serious Injury or Death from Suffocation; Violate Mandatory Standards fo…
Xishentang Dongguan Trading Co, Ltd., dba Pretty-Life, of China · 2026-07-02
CPSC Moderate
Diamond Wipes International Recalls CVS Health Medicated Hemorrhoidal Wipes Due to Risk of Serious Injury or Death from…
Diamond Wipes International, Inc. of Chino, California · 2026-07-02
CPSC Moderate
Junpower CR2032 Lithium Coin Batteries Recalled Due to Risk of Serious Injury or Death from Battery Ingestion Hazard; V…
· 2026-07-02
CPSC Moderate
Target Recalls Gigglescape™ Under the Sea Popping Toy Due to Choking Hazard
· 2026-07-02
CPSC Moderate
Vevor Recalls Baby Loungers Due to Risk of Serious Injury or Death from Entrapment and Fall Hazards; Violate Mandatory …
Sanven Technology Ltd., dba Vevor, of Rancho Cucamonga, California · 2026-07-02
Compare this recall with AMASKY Nursing Pillows Recalled Due to Risk of Serious Inju… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported October 13, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.